Spitfire List Web site and blog of anti-fascist researcher and radio personality Dave Emory.

For The Record  

FTR#1258 Pandemics, Inc., Part 8: Covid Update

You can sub­scribe to RSS feed from Spitfirelist.com HERE.

You can sub­scribe to the com­ments made on pro­grams and posts–an excel­lent source of infor­ma­tion in, and of, itself, HERE.

WFMU-FM is pod­cast­ing For The Record–You can sub­scribe to the pod­cast HERE.

Mr. Emory’s entire life’s work is avail­able on a 32GB flash dri­ve, avail­able for a con­tri­bu­tion of $65.00 or more (to KFJC). Click Here to obtain Dav­e’s 40+ years’ work, com­plete through Late Fall of 2021 (through FTR #1215).

“Polit­i­cal language…is designed to make lies sound truth­ful and mur­der respectable, and to give an appear­ance of solid­i­ty to pure wind.”

— George Orwell, 1946

EVERYTHING MR. EMORY HAS BEEN SAYING ABOUT THE UKRAINE WAR IS ENCAPSULATED IN THIS VIDEO FROM UKRAINE 24

ANOTHER REVEALING VIDEO FROM UKRAINE 24

Mr. Emory has launched a new Patre­on site. Vis­it at: Patreon.com/DaveEmory

FTR#1258 This pro­gram was record­ed in one, 60-minute seg­ment.

Intro­duc­tion: Updat­ing the Covid-19 pan­dem­ic, this broad­cast explores trou­bling devel­op­ments in the admin­is­tra­tion of aspects of the pan­dem­ic.

NB: Mr. Emory is not an anti-vaxxer. When prop­er­ly man­u­fac­tured and vet­ted, they are fun­da­men­tal to the main­te­nance of pub­lic health.

The dis­turb­ing aspects of Biden’s vac­cine pol­i­cy sug­gest the pos­si­bil­i­ty that the reg­u­la­to­ry hand­i­cap­ping of the FDA advo­cat­ed by Trump backer Peter Thiel and his ide­o­log­i­cal fel­low trav­el­ers may have been imple­ment­ed, under the pres­sure of the pan­dem­ic.

That de-reg­u­la­tion of the FDA may have car­ried over into Avi­a­tor Glass­es Joe’s admin­is­tra­tion.

An inter­est­ing and trou­bling sto­ry con­cerns the FDA’s “thumbs down” on the John­son & John­son vac­cine because of a blood-clot­ting dis­or­der that affects 3.25 recip­i­ents per mil­lion. There have been a total of nine deaths from the dis­or­der out of 18 mil­lion recip­i­ents of the vac­cine.

The mRNA vac­cines, by way of con­trast, pro­duce a seri­ous con­di­tion called myocardi­tis in strong, healthy adults. That strikes eleven in every one hun­dred thou­sand recip­i­ents.

One must won­der why this con­clu­sion was reached. Is there Big Phar­ma prof­it-mak­ing con­sid­er­a­tions at play here? Or is the read­i­ly-adapt­able mRNA tech­nol­o­gy to new organ­isms that might be craft­ed as part of a bio­log­i­cal war­fare pro­gram loom­ing in the back­ground of such a deci­sion?

An even more dis­turb­ing, per­haps relat­ed, arti­cle con­cerns sub­stan­tive indi­ca­tions that the much-maligned John­son & John­son vac­cine is more effec­tive than its mRNA com­peti­tors.

It may pro­vide bet­ter pro­tec­tion against the Omi­cron vari­ant.

” . . . . By now, all the vac­cines seem to be per­form­ing about equal­ly well against coro­n­avirus infec­tions; in fact, John­son & John­son appears to be hold­ing up slight­ly bet­ter. . . . Over­all, then, the John­son & John­son vac­cine appeared to be some­what more pro­tec­tive against infec­tion than the two alter­na­tives. . . . . . The J.&J. vac­cine may pro­duce anti­bod­ies that decline more slow­ly than those pro­duced by the oth­er vac­cines, some research sug­gests. Or those anti­bod­ies may become more sophis­ti­cat­ed over time, through a bio­log­i­cal phe­nom­e­non called affin­i­ty mat­u­ra­tion. . . . Per­haps, some researchers sug­gest, the vac­cine offered a more robust defense against the Omi­cron vari­ant, respon­si­ble for the huge increase in infec­tions over the past few months. And stud­ies have shown that the vac­cine trains oth­er parts of the immune sys­tem at least as well as the oth­er two vac­cines. . . .”

Anoth­er stun­ning devel­op­ment con­cerns the FDA’s deci­sion to vet the next gen­er­a­tion of [mRNA] boost­ers with mouse tri­als, instead of human!

” . . . . ‘For the FDA to rely on mouse data is just bizarre, in my opin­ion,’ says John Moore, an immu­nol­o­gist at Weill Cor­nell Med­i­cine in New York. ‘Mouse data are not going to be pre­dic­tive in any way of what you would see in humans.’ . . . .”

WHY?

Peter Thiel favored “kneecap­ping the FDA” in order to bring Big Phar­ma’s prod­ucts to mar­ket soon­er, in full aware­ness of the col­lat­er­al dam­age that would result from this.

” . . . . For Food and Drug Admin­is­tra­tion com­mis­sion­er, he [Thiel] attempt­ed to nom­i­nate can­di­dates who shared his belief that the FDA’s main role—regarding tri­als for drugs—was unnec­es­sary. One of Thiel’s allies in this cru­sade, and his top pick to lead the FDA, was Bal­a­ji Srini­vasan, the Stan­ford com­put­er sci­ence lec­tur­er and cryp­tocur­ren­cy entre­pre­neur who’s invest­ed along­side Thiel in Cur­tis Yarvin’s com­pa­ny and shared Thiel’s views. . . . ‘For every thalido­mide,’ he tweet­ed, “many dead from slowed approvals.” . . . . Thiel had argued much the same. . . .”

Note that the FDA’s reg­u­la­to­ry “red light” on the use of thalido­mide saved the U.S. from the birth defects night­mare expe­ri­enced by Europe.

We note in that regard that Thiel comes from an “I.G.” back­ground, to coin a term. As not­ed in FTR #718, Thiel’s father was a chem­i­cal engi­neer from Frank­furt, the cap­i­tal of I.G.

After the pan­dem­ic, Thiel seemed pleased at that event, main­tain­ing that it had pro­ject­ed us into the future. ” . . . . ‘COVID-19 cre­at­ed a shift. There used to be this feel­ing that the future was being held back some­how. Changes that should have tak­en place long ago did not come because there was resis­tance. Now the future is set free.’ He was, it seemed, wel­com­ing the pan­dem­ic as a chance to reset soci­ety accord­ing to his ideals and plans. . . .”

Joe Biden’s pol­i­cy vis a vis Covid may well be eugeni­cist in its ori­en­ta­tion. Return­ing to “nor­mal,” in most respects, but allow­ing the virus to cir­cu­late, plac­ing seniors–no longer in the workforce–at risk

We have not­ed that Biden’s social poli­cies appear to be exten­sions of his nation­al secu­ri­ty pol­i­cy. He has stat­ed that com­pet­ing with Chi­na is a pri­or­i­ty.

In that regard, trim­ming expens­es, includ­ing the rel­a­tive­ly expen­sive social pro­grams need­ed to care for the elder­ly, is appar­ent­ly on the front burn­er. 

Bot­tom line: old folks don’t work.

” . . . . ‘And the ques­tion I have is, how much death are we OK with?’ she asks. ‘Have we decid­ed this is OK? And if so, why?’ . . . . Covid-19 has always been a dis­ease of the elder­ly, defined almost more by its age skew of mor­tal­i­ty than by any of its oth­er char­ac­ter­is­tics, with risk dou­bling rough­ly every eight years and octo­ge­nar­i­ans hun­dreds of times more at risk of death than young adults. . . .”

Indica­tive of Biden’s cyn­i­cism on social and eco­nom­ic pol­i­cy is his selec­tion to serve on the Social Secu­ri­ty Admin­is­tra­tion:

” . . . . Defend­ers of Social Secu­ri­ty on Tues­day urged the U.S. Sen­ate to block Pres­i­dent Joe Biden’s lit­tle-noticed nom­i­na­tion of Andrew Big­gs — an Amer­i­can Enter­prise Insti­tute senior fel­low with a his­to­ry of sup­port­ing Social Secu­ri­ty pri­va­ti­za­tion — to serve on the inde­pen­dent and bipar­ti­san Social Secu­ri­ty Advi­so­ry Board. . . . Biden was vice pres­i­dent when for­mer Pres­i­dent Barack Oba­ma pro­posed a ‘grand bar­gain’ with the GOP that would have entailed cuts to Social Secu­ri­ty. Big­gs, too, has a long record of advo­cat­ing Social Secu­ri­ty cuts. As Cun­ning­ham-Cook wrote last month, ‘For years, Big­gs has been a vocal crit­ic of expand­ed Social Secu­ri­ty and work­ers’ right to a secure, sta­ble retire­ment free from the vagaries of the stock mar­ket.’. . .”

1a.

In a new­ly filed law­suit, Mod­er­na asserts that the Pfizer/BioNTech mRNA coro­n­avirus vac­cines are infring­ing on Moderna’s patents. What’s eye­brow-rais­ing in this law­suit is the time­frame of Moderna’s claims. The com­pa­ny is argu­ing that Pfizer’s vac­cine copied work Mod­er­na had already done on coro­n­avirus vac­cines involv­ing human tri­als going back to 2015 and 2016. Beyond that, Mod­er­na asserts the full-sequence coro­n­avirus spike pro­tein used in Pfizer’s vac­cine was devel­oped by Mod­er­na years before the pan­dem­ic.

Per­haps the biggest set of ques­tions that might be answered in this law­suit involve Moderna’s pos­si­ble col­lab­o­ra­tive role in the broad­er US-gov­ern­ment-fund­ed gain-of-func­tion research being lead by the Eco­HealthAl­liance in col­lab­o­ra­tion with labs around the world like Shi Zhengli’s lab at the Wuhan Insti­tute of Virol­o­gy (WIV) and Ralph Baric’s lab at UNC Chapel Hill. As we’ve seen, Ralph Bar­ic was work­ing on devel­op­ing coro­n­avirus ther­a­peu­tics back in 2017 using gain-of-func­tion-cre­at­ed coro­n­avirus­es in col­lab­o­ra­tion with Shi Zhengli’s lab at the WIV. And Bar­ic also helped test the Mod­er­na covid vac­cine in 2020. So was Mod­er­na – which was fund­ed by DARPA – at all involved in this oth­er NIH-fund­ed coro­n­avirus-relat­ed gain-of-func­tion work? The cir­cum­stan­tial evi­dence sure points in that direc­tion.

Above all, there’s the part of the law­suit claim­ing that Pfiz­er effec­tive­ly stole the full-sequence coro­n­avirus spike pro­tein sequence Mod­er­na had worked out years ear­li­er.

This is a con­fus­ing part of the law­suit since, as we’ve been told, it was the SARS-CoV­‑2 spike pro­tein sequence that was at the heart of the mRNA COVID vac­cine devel­oped in record-break­ing time back in Jan­u­ary of 2020.

What is Mod­er­na talk­ing about when claim­ing that it already devel­oped a coro­n­avirus spike pro­tein years ear­li­er? Recall how Mod­er­na was crit­i­cized back in 2020 over its deci­sion to file a patent in Feb 2020 for a “Beta­coro­n­avirus vac­cine” – a broad-spec­trum vac­cine designed for non-COVID coro­n­avirus­es – with­out acknowl­edg­ing the US gov­ern­ments role in that researchPfizer/BioNTech filed a patent for a sim­i­lar “uni­ver­sal coro­n­avirus vac­cine” back in June.

It appears that’s what Mod­er­na is refer­ring to when it claims to have devel­oped a coro­n­avirus spike pro­tein sequence years before the pan­dem­ic. That rais­es the obvi­ous ques­tion: was Mod­er­na part of the whole Eco­HealthAl­liance gain-of-func­tion research on coro­n­avirus­es back in their 2015–2016 peri­od?

Gain-of-func­tion research was tech­ni­cal­ly banned in the US from 2014 until the Trump admin­is­tra­tion lift­ed it in 2017. Recall, also, how Baric’s gain-of-func­tion work that was start­ed before the mora­to­ri­um was put into place was allowed to con­tin­ue under a spe­cial exemp­tion.

If Moderna’s coro­n­avirus vac­cine devel­op­ment involved the use of virus­es being gen­er­at­ed by Bar­ic under an exemp­tion to the gain-of-func­tion mora­to­ri­um, that would obvi­ous­ly be a very sen­si­tive area of research.

There’s anoth­er facet of this sto­ry to keep in mind: recall that fas­ci­nat­ing Sep­tem­ber 2016 STAT News arti­cle that described how Mod­er­na had shift­ed its focus from mRNA ther­a­peu­tics – which require numer­ous shots over years – to mRNA vac­cines. It was seen as as dis­ap­point­ment by indus­try observers and sign that Mod­er­na was run­ning into undis­closed set­backs involv­ing side effects trig­gered by the lipid nanopar­ti­cle (LNP) deliv­ery vehi­cle for the mRNA. But as we saw, Mod­er­na was insist­ing at the time that it was expe­ri­enc­ing no such set­backs. And yet observers were forced to take their word because the com­pa­ny was being so secre­tive and releas­ing almost no infor­ma­tion about its inter­nal tri­als.

There is no men­tion of coro­n­avirus-relat­ed research at all in that arti­cle, while there is men­tion of work on things like a Zika virus vac­cine.

Yet, in the new law­suit, Mod­er­na claims it suc­cess­ful­ly car­ried out human tri­als on a coro­n­avirus vac­cine as far back as 2015. It would seem that Moderna’s coro­n­avirus-relat­ed vac­cine research was being kept under wraps dur­ing this peri­od.

We have to ask if the extreme secre­cy around its work dur­ing this peri­od may have been dri­ven by the con­tro­ver­sial nature of devel­op­ing coro­n­avirus vac­cines using gain-of-func­tion coro­n­avirus­es gen­er­at­ed by the Eco­HealthAl­liance net­work. Cir­cum­stan­tial evi­dence points in that direc­tion. 

Mod­er­na is appar­ent­ly suing over patents it devel­oped dur­ing its most­ly-still-secret DARPA col­lab­o­ra­tion. Col­lab­o­ra­tion that might be direct­ly relat­ed to the most­ly-still-secret US-gov­ern­ment-financed inter­na­tion­al col­lab­o­ra­tion ded­i­cat­ed to mak­ing and study­ing nov­el coro­n­avirus­es. Law­suits have a ten­den­cy to unin­ten­tion­al­ly reveal secrets. Thereis clear­ly an abun­dance of secrets still wait­ing to be revealed about Moderna’s coro­n­avirus vac­cine research.

Again, we empha­size the fol­low­ing very inter­est­ing detail in Moderna’s com­plaint: the com­pa­ny is assert­ing that Pfiz­er and BioN­Tech copied Moderna’s full-length spike pro­tein for­mu­la­tion for a coro­n­avirus, which Mod­ern claims to have cre­at­ed years before the emer­gence of COVID-19.

Recall how the shar­ing of the genet­ic sequence of SARS-CoV­‑2 by Chi­nese researchers with the glob­al com­mu­ni­ty allowed for Mod­er­na to and its NIH col­lab­o­ra­tors to design the vac­cine in just two days with just that spike pro­tein sequence infor­ma­tion.

Once again, Mod­er­na is suing Pfiz­er over the alleged theft of a coro­n­avirus spike pro­tein sequence devel­oped years ear­li­er, we have to ask whether or not this part of the law­suit is relat­ed to the “uni­ver­sal coro­n­avirus” vac­cine Pfiz­er and BioN­Tech start­ed test­ing back in June.

Note, again, that Mod­er­na caught flack back in August of 2020 after it filed patents relat­ed to the coro­n­avirus vac­cine that didn’t dis­close the bil­lions in dol­lars in DARPA mon­ey, includ­ing DARPA involve­ment in the devel­op­ment of a broad spec­turm “Beta­coro­n­avirus” vac­cine that Mod­er­na had filed a patent for in Feb­ru­ary 2020.

That, again, returns us to ques­tions regard­ing Moderna’s involve­ment with the pre-pan­dem­ic gain-of-func­tion coro­n­avirus research car­ried out by the Eco­Health Alliance and col­lab­o­ra­tors like the WIV. Because as we’ve seen, the cre­ation of a broad-spec­trum coro­n­avirus vac­cine was part of the pre-pan­dem­ic work done by the Eco­HealthAl­liance, the WIV, and Ralph Baric’s lab at UNC Chapel Hill.

Was Mod­er­na involved in that broad-spec­trum coro­n­avirus vac­cine research? It appears to have been the case.

“Mod­er­na Sues Pfiz­er and BioN­Tech Over Covid Vac­cine” By Jen­ny Gross and Rebec­ca Rob­bins; The New York Times; 08/26/2022

The law­suit, filed Fri­day, claims that the com­pa­nies’ Covid vac­cine vio­lat­ed Moderna’s mRNA patents.

The vac­cine man­u­fac­tur­er Mod­er­na sued Pfiz­er and BioN­Tech on Fri­day, claim­ing that its rivals’ Covid-19 shot vio­lates its patents pro­tect­ing its ground­break­ing tech­nol­o­gy.

Mod­er­na said in a state­ment that Pfiz­er and BioN­Tech infringed on patents filed between 2010 and 2016 that cov­ered its mRNA tech­nol­o­gy. Mod­er­na, which is based in Cam­bridge, Mass., sued in U.S. Dis­trict Court in Mass­a­chu­setts and the Region­al Court of Düs­sel­dorf in Ger­many, where BioN­Tech is based.

Christo­pher Rid­ley, a spokesman for Mod­er­na, said the com­pa­ny did not have an esti­mate for the amount of dam­ages it was seek­ing.

Pfiz­er and its devel­op­ment part­ner BioN­Tech were “sur­prised by the lit­i­ga­tion,” said Jer­i­ca Pitts, a spokes­woman for Pfiz­er. She added that the com­pa­nies “remain con­fi­dent in our intel­lec­tu­al prop­er­ty sup­port­ing the Pfizer/BioNTech vac­cine and will vig­or­ous­ly defend against the alle­ga­tions of the law­suit.”

Mes­sen­ger RNA, or mRNA, is the genet­ic script that car­ries DNA instruc­tions to each cell’s pro­tein-mak­ing machin­ery and has been used in the pro­duc­tion of coro­n­avirus vac­cines.

“We are fil­ing these law­suits to pro­tect the inno­v­a­tive mRNA tech­nol­o­gy plat­form that we pio­neered, invest­ed bil­lions of dol­lars in cre­at­ing, and patent­ed dur­ing the decade pre­ced­ing the Covid-19 pan­dem­ic,” said Stéphane Ban­cel, Moderna’s chief exec­u­tive. “This foun­da­tion­al plat­form, which we began build­ing in 2010, along with our patent­ed work on coro­n­avirus­es in 2015 and 2016, enabled us to pro­duce a safe and high­ly effec­tive Covid-19 vac­cine in record time after the pan­dem­ic struck.”

Mod­er­na, which received close to $10 bil­lion in tax­pay­er fund­ing to devel­op the vac­cine, test it and pro­vide dos­es to the fed­er­al gov­ern­ment, had said in fall 2020 that it would not enforce its Covid-relat­ed patents while the pan­dem­ic con­tin­ued. But on March 7, the com­pa­ny said that said that it was updat­ing its pledge, since vac­cine sup­ply was no longer an issue out­side the poor­est coun­tries. It said it expect­ed man­u­fac­tur­ers out­side the 92 poor­est coun­tries to respect the company’s intel­lec­tu­al prop­er­ty. At the time, it also said that it was expand­ing its patent pledge to nev­er enforce Covid patents for 92 low- and mid­dle-income coun­tries.

Mod­er­na said on Fri­day that it was not seek­ing dam­ages for activ­i­ties before March 8 and that none of the patents relate to intel­lec­tu­al prop­er­ty gen­er­at­ed dur­ing Moderna’s col­lab­o­ra­tion with the Nation­al Insti­tutes of Health on Covid-19, which it said began only after patent­ed tech­nolo­gies were proven suc­cess­ful in 2015 and 2016.

Mod­er­na said that Pfiz­er copied two fea­tures of its patent­ed tech­nol­o­gy. First, Pfiz­er took four vac­cine can­di­dates into clin­i­cal test­ing, but ulti­mate­ly pro­ceed­ed with a vac­cine with the same mRNA tech­nol­o­gy as the Mod­er­na vac­cine. Mod­er­na said it was the first com­pa­ny to val­i­date this tech­nol­o­gy in human tri­als in 2015, and that nei­ther Pfiz­er nor BioN­Tech had its lev­el of expe­ri­ence in devel­op­ing mRNA vac­cines for infec­tious dis­eases.

Sec­ond, Mod­er­na claims that Pfiz­er and BioN­Tech copied its full-length spike pro­tein for­mu­la­tion for a coro­n­avirus, which Mod­er­na had cre­at­ed years before Covid-19 emerged. Coro­n­avirus­es refer to a large fam­i­ly of virus­es that cause mild to mod­er­ate upper res­pi­ra­to­ry tract ill­ness­es, accord­ing to the N.I.H. The more seri­ous ones include SARS, MERS and Covid-19.

Mod­er­na said it was not seek­ing to remove Pfiz­er and BioNTech’s vac­cines from the mar­ket, and was not ask­ing for an injunc­tion to pre­vent their future sale, giv­en the need for access to coro­n­avirus vac­cines. . . .

1b. An inter­est­ing and trou­bling sto­ry con­cerns the FDA’s “thumbs down” on the John­son & John­son vac­cine because of a blood-clot­ting dis­or­der that affects 3.25 recip­i­ents per mil­lion. There have been a total of nine deaths from the dis­or­der out of 18 mil­lion recip­i­ents of the vac­cine.

The mRNA vac­cines, by way of con­trast, pro­duce a seri­ous con­di­tion called myocardi­tis in strong, healthy adults. That strikes eleven in every one hun­dred thou­sand recip­i­ents.

One must won­der why this con­clu­sion was reached. Is there Big Phar­ma prof­it-mak­ing con­sid­er­a­tions at play here? Or is the read­i­ly-adapt­able mRNA tech­nol­o­gy to new organ­isms that might be craft­ed as part of a bio­log­i­cal war­fare pro­gram loom­ing in the back­ground of such a deci­sion?

“FDA lim­its use of John­son & Johnson’s Covid-19 vac­cine, cit­ing clot­ting risk” by Helen Bran­swell; STAT News; 05/05/2022

. . . . Peter Marks, the FDA’s vac­cines lead, told STAT the agency reached its deci­sion after a recent review of the data on the vac­cine revealed anoth­er per­son in this coun­try had died after receiv­ing it — the ninth such death — in the first quar­ter of the year. The vac­cine is made by J&J’s vac­cines divi­sion, Janssen.

“If we see deaths and there is an alter­na­tive vac­cine that is not asso­ci­at­ed with deaths but is asso­ci­at­ed with sim­i­lar effi­ca­cy … we felt it was time at this point to make a state­ment on the [product’s] fact sheet that this was not a first-line vac­cine,” said Marks, who is direc­tor of the FDA’s Cen­ter for Bio­log­ics Eval­u­a­tion and Research.

The clot­ting dis­or­der, called throm­bo­sis with throm­bo­cy­tope­nia or TTS, is rare, occur­ring at a rate of about 3.25 cas­es per mil­lion dos­es admin­is­tered. But the con­di­tion can be fatal or life-alter­ing if an indi­vid­ual sur­vives. With one death for every 2 mil­lion dos­es giv­en in this coun­try, the FDA decid­ed that is a risk most peo­ple don’t need to take, Marks said. . . .

. . . . He acknowl­edged the lat­est announce­ment won’t change much on the ground in the Unit­ed States, where few vac­ci­na­tion sites stock the J&J vac­cine at this point. But it could have impli­ca­tions abroad, where coun­tries still strug­gling to vac­ci­nate their pop­u­laces could be influ­enced by the U.S. deci­sion. . . .

———

2. An even more dis­turb­ing, per­haps relat­ed, arti­cle con­cerns sub­stan­tive indi­ca­tions that the much-maligned John­son & John­son vac­cine is more effec­tive than its mRNA com­peti­tors.

It may pro­vide bet­ter pro­tec­tion against the Omi­cron vari­ant.

” . . . . By now, all the vac­cines seem to be per­form­ing about equal­ly well against coro­n­avirus infec­tions; in fact, John­son & John­son appears to be hold­ing up slight­ly bet­ter. . . . Over­all, then, the John­son & John­son vac­cine appeared to be some­what more pro­tec­tive against infec­tion than the two alter­na­tives. . . . . . The J.&J. vac­cine may pro­duce anti­bod­ies that decline more slow­ly than those pro­duced by the oth­er vac­cines, some research sug­gests. Or those anti­bod­ies may become more sophis­ti­cat­ed over time, through a bio­log­i­cal phe­nom­e­non called affin­i­ty mat­u­ra­tion. . . . Per­haps, some researchers sug­gest, the vac­cine offered a more robust defense against the Omi­cron vari­ant, respon­si­ble for the huge increase in infec­tions over the past few months. And stud­ies have shown that the vac­cine trains oth­er parts of the immune sys­tem at least as well as the oth­er two vac­cines. . . .”

“As Virus Data Mounts, the J.&J. Vac­cine Holds Its Own” By Apoor­va Man­davil­li; The New York Times; 03/15/2022

Rough­ly 17 mil­lion Amer­i­cans received the John­son & John­son Covid vac­cine, only to be told lat­er that it was the least pro­tec­tive of the options avail­able in the Unit­ed States. But new data sug­gest that the vac­cine is now pre­vent­ing infec­tions, hos­pi­tal­iza­tions and deaths at least as well as the Pfiz­er-BioN­Tech and Mod­er­na vac­cines.

The rea­sons aren’t clear, and not all experts are con­vinced that the vac­cine has vin­di­cat­ed itself. But the accu­mu­lat­ing data nonethe­less offer con­sid­er­able reas­sur­ance to recip­i­ents of the vac­cine and, if con­firmed, have broad impli­ca­tions for its deploy­ment in parts of the world.

In Africa, for exam­ple, dis­tri­b­u­tion of a sin­gle-dose vac­cine that can be refrig­er­at­ed for months is by far the most prac­ti­cal option.

John­son & John­son has at least tem­porar­i­ly shut down the only plant mak­ing usable batch­es of the vac­cine. But the South Africa-based Aspen Phar­ma­care is gear­ing up to sup­ply large quan­ti­ties to the rest of the con­ti­nent. Only about 13 per­cent of Africans are ful­ly vac­ci­nat­ed, and only about 1 per­cent have received a boost­er dose. . . .

. . . . But the notion that the vac­cine is infe­ri­or has grown out­dat­ed, some experts said: More recent data sug­gest that it has more than held its own against its com­peti­tors.

“We’ve been aware that J.&J. has been kind of down­grad­ed in people’s minds,” Dr. Gail-Bekker said. But “it punch­es above its weight for a sin­gle-dose vac­cine.”

Until last June, the cumu­la­tive data from the C.D.C. showed that immu­niza­tion with the Mod­er­na vac­cine result­ed in the low­est rates of break­through infec­tions; those who got John­son & John­son saw the high­est rates, with Pfiz­er-BioN­Tech some­where in the mid­dle.

Dur­ing the sum­mer months, the gaps — par­tic­u­lar­ly between J.&J. and Pfiz­er — began to nar­row. By now, all the vac­cines seem to be per­form­ing about equal­ly well against coro­n­avirus infec­tions; in fact, John­son & John­son appears to be hold­ing up slight­ly bet­ter.

As of Jan. 22, the lat­est data avail­able, unvac­ci­nat­ed peo­ple were 3.2 times as like­ly to become infect­ed as those who received the sin­gle-dose John­son & John­son vac­cine; they were 2.8 times as like­ly to become infect­ed as those who received two dos­es of the Mod­er­na vac­cine and 2.4 times as like­ly as those with two dos­es of Pfiz­er-BioN­Tech. Over­all, then, the John­son & John­son vac­cine appeared to be some­what more pro­tec­tive against infec­tion than the two alter­na­tives. . . . . .

. . . . The find­ings indi­cate that the J.&J. vac­cine deserves a clos­er look, said Dr. Lar­ry Corey, an expert in vac­cine devel­op­ment at the Fred Hutchin­son Can­cer Research Cen­ter in Seat­tle.

“This vac­cine plat­form may have some sur­pris­ing char­ac­ter­is­tics that we hadn’t antic­i­pat­ed,” he said. The data “is inter­est­ing, provoca­tive, and we should spend more time under­stand­ing it.”

Dr. Corey said the results jibe with his expe­ri­ence in H.I.V. research with the ade­n­ovirus that forms the back­bone of the John­son & John­son vac­cine. “It has much longer dura­bil­i­ty than almost any oth­er plat­form that we’ve ever worked with,” he said.

Sci­en­tists are only begin­ning to guess why the vaccine’s pro­file is improv­ing with the pass­ing months.

Lev­els of anti­bod­ies sky­rock­et in the first few weeks after immu­niza­tion, but then rapid­ly wane. The J.&J. vac­cine may pro­duce anti­bod­ies that decline more slow­ly than those pro­duced by the oth­er vac­cines, some research sug­gests. Or those anti­bod­ies may become more sophis­ti­cat­ed over time, through a bio­log­i­cal phe­nom­e­non called affin­i­ty mat­u­ra­tion.

Per­haps, some researchers sug­gest, the vac­cine offered a more robust defense against the Omi­cron vari­ant, respon­si­ble for the huge increase in infec­tions over the past few months. And stud­ies have shown that the vac­cine trains oth­er parts of the immune sys­tem at least as well as the oth­er two vac­cines. . . .

3. Anoth­er stun­ning devel­op­ment con­cerns the FDA’s deci­sion to vet the next gen­er­a­tion of [mRNA] boost­ers with mouse tri­als, instead of human!

” . . . . ‘For the FDA to rely on mouse data is just bizarre, in my opin­ion,’ says John Moore, an immu­nol­o­gist at Weill Cor­nell Med­i­cine in New York. ‘Mouse data are not going to be pre­dic­tive in any way of what you would see in humans.’ . . . .”

WHY?

“What’s behind the FDA’s con­tro­ver­sial strat­e­gy for eval­u­at­ing new COVID boost­ers” by Rob Stein; npr.org; 8/18/2022.

The U.S. Food and Drug Admin­is­tra­tion is using a con­tro­ver­sial strat­e­gy to eval­u­ate the next gen­er­a­tion of COVID-19 boost­ers.

The approach is stir­ring debate as the agency works to make new, hope­ful­ly improved, boost­ers avail­able in Sep­tem­ber to help pre­vent severe dis­ease and save lives in the fall and win­ter.

For the first time, the FDA is plan­ning to base its deci­sion about whether to autho­rize new boost­ers on stud­ies involv­ing mice instead of humans. 

“For the FDA to rely on mouse data is just bizarre, in my opin­ion,” says John Moore, an immu­nol­o­gist at Weill Cor­nell Med­i­cine in New York. “Mouse data are not going to be pre­dic­tive in any way of what you would see in humans.” . . . .

But oth­ers defend the approach, argu­ing that the coun­try has had enough expe­ri­ence with the vac­cines at this point to be con­fi­dent the shots are safe and that there’s not enough time to wait for data from human stud­ies.

“We have 500 peo­ple a day dying of coro­n­avirus right now. Those num­bers sad­ly might very well rise in the fall and the win­ter. The ques­tion is: ‘Can we do some­thing bet­ter?’ ” says Dr. Ofer Levy, a pedi­atrics and infec­tious dis­ease researcher at Har­vard Med­ical School who also advis­es the FDA. “And I think the answer is: ‘We can, by imple­ment­ing this approach.’ ” . . .

. . . . But the big con­cern is the boost­ers may not work as well as the mouse data might sug­gest. Mouse exper­i­ments are noto­ri­ous­ly unre­li­able. . . .

. . . . “We need to make sure that we have sol­id immuno­genic­i­ty data in peo­ple to show that you have a dra­mat­i­cal­ly greater neu­tral­iz­ing anti­body response against BA.4, BA.5,” says Dr. Paul Offit of the Uni­ver­si­ty of Penn­syl­va­nia, who also advis­es the FDA. “I think any­thing short of that is not accept­able.” . . .

4. Peter Thiel favored “kneecap­ping the FDA” in order to bring Big Phar­ma’s prod­ucts to mar­ket soon­er, in full aware­ness of the col­lat­er­al dam­age that would result from this.

” . . . . For Food and Drug Admin­is­tra­tion com­mis­sion­er, he [Thiel] attempt­ed to nom­i­nate can­di­dates who shared his belief that the FDA’s main role—regarding tri­als for drugs—was unnec­es­sary. One of Thiel’s allies in this cru­sade, and his top pick to lead the FDA, was Bal­a­ji Srini­vasan, the Stan­ford com­put­er sci­ence lec­tur­er and cryp­tocur­ren­cy entre­pre­neur who’s invest­ed along­side Thiel in Cur­tis Yarvin’s com­pa­ny and shared Thiel’s views. . . . ‘For every thalido­mide,’ he tweet­ed, “many dead from slowed approvals.” . . . . Thiel had argued much the same. . . .”

Note that the FDA’s reg­u­la­to­ry “red light” on the use of thalido­mide saved the U.S. from the birth defects night­mare expe­ri­enced by Europe.

We note in that regard that Thiel comes from an “I.G.” back­ground, to coin a term. As not­ed in FTR #718, Thiel’s father was a chem­i­cal engi­neer from Frank­furt, the cap­i­tal of I.G.

The Con­trar­i­an by Max Chafkin; Pen­guin Press [HC]; Copy­right 2021 by Max Chafkin; ISBN 9781984878533; p9. 253–254.

. . . . For Food and Drug Admin­is­tra­tion com­mis­sion­er, he [Thiel] attempt­ed to nom­i­nate can­di­dates who shared his belief that the FDA’s main role—regarding tri­als for drugs—was unnec­es­sary.

The con­sen­sus view among drug devel­op­ers, even many in Sil­i­con Val­ley, has been that “you don’t want to put indi­vid­u­als at risk,” said Zach Wein­berg, the cofounder of Flat­iron Health, a Sil­i­con Val­ley-backed med­ical research firm that is now owned by the phar­ma­ceu­ti­cal giant Roche. “Peter Thiel’s view is that will slow things down. His whole game is if a few peo­ple get hurt and that cre­ates progress, he’s will­ing to take that trade.” 

One of Thiel’s allies in this cru­sade, and his top pick to lead the FDA, was Bal­a­ji Srini­vasan, the Stan­ford com­put­er sci­ence lec­tur­er and cryp­tocur­ren­cy entre­pre­neur who’s invest­ed along­side Thiel in Cur­tis Yarvin’s com­pa­ny and shared Thiel’s views. . . . 

 . . . . “For every thalido­mide,” he tweet­ed, “many dead from slowed approvals.” . . . .

Thiel had argued much the same. . . .

. . . . the agency’s [FDA] refusal in the ear­ly 1960’s to approve thalido­mide, a sleep­ing pill, is regard­ed as one of the great admin­is­tra­tive suc­cess sto­ries. In Europe, where a less-reg­u­lat­ed mar­ket allowed thalido­mide to be pre­scribed to preg­nant women, thou­sands of babies were born with­out ful­ly formed limbs. . . .

. . . . Thiel’s oth­er choice to run the FDA was Jim O’Neill, who’d run the Thiel Foun­da­tion and had since worked as an investor at Mithril, Ajay Royan’s ven­ture cap­i­tal firm . . . . He also believed in rolling back the FDA man­dates about drug effi­ca­cy. . . .

5. After the pan­dem­ic, Thiel seemed pleased at that event, main­tain­ing that it had pro­ject­ed us into the future. ” . . . . ‘COVID-19 cre­at­ed a shift. There used to be this feel­ing that the future was being held back some­how. Changes that should have tak­en place long ago did not come because there was resis­tance. Now the future is set free.’ He was, it seemed, wel­com­ing the pan­dem­ic as a chance to reset soci­ety accord­ing to his ideals and plans. . . .”

The Con­trar­i­an by Max Chafkin; Pen­guin Press [HC]; Copy­right 2021 by Max Chafkin; ISBN 9781984878533; p9. 327–328.

. . . . How could any­one devot­ed to life exten­sion not be moved by so many pre­ventable deaths? By late March more than 550,000 Amer­i­cans had died from Covid, mak­ing the pan­dem­ic dead­lier than U.S. casu­al­ties in World War I and World War II com­bined. The Unit­ed States has suf­fered one of the worst per-capi­ta mor­tal­i­ty rates in the world. How had those grim fig­ures not moved him to break with Trump or to at last spend more ambi­tious­ly to help? . . . .

. . . . Thiel spoke to Die Welt­woche, a Swiss news­pa­per whose edi­tor Roger Kop­pel is a mem­ber of the country’s nation­al-con­ser­v­a­tive People’s Par­ty. Dur­ing an inter­view with Kop­pel, Thiel char­ac­ter­ized the dis­ease as a men­tal pathol­o­gy rather than a phys­i­cal one. “I see it as a psy­cho­log­i­cal indi­ca­tor that peo­ple know deep down: There is no way back to the old nor­mal,” he said.

He con­tin­ued: “COVID-19 cre­at­ed a shift. There used to be this feel­ing that the future was being held back some­how. Changes that should have tak­en place long ago did not come because there was resis­tance. Now the future is set free.” He was, it seemed, wel­com­ing the pan­dem­ic as a chance to reset soci­ety accord­ing to his ideals and plans. . . .

6. In an alto­geth­er spec­u­la­tive ele­ment, we review dis­cus­sion of Nazi chem­i­cal giant I.G. Far­ben’s influ­ence in the phar­ma­ceu­ti­cal busi­ness, the pro­gram access­es infor­ma­tion about the tran­quil­iz­er thalido­mide. When pre­scribed for preg­nant women in the ear­ly 1960’s, it led to hor­ri­bly deformed babies. A new book claims that the drug was actu­al­ly invent­ed by the Nazis and test­ed in con­cen­tra­tion camps dur­ing World War II.

“Thalido­mide ‘Cre­at­ed by Nazis’ ” [TimesOn­line]; The Aus­tralian; 2/08/2009.

“The morn­ing sick­ness drug thalido­mide, which caused preg­nant women to give birth to babies with­out arms and legs, was first devel­oped by the Nazis, prob­a­bly as part of their chem­i­cal weapons pro­gramme, accord­ing to new research.

Two sep­a­rate aca­d­e­mics have revealed the dis­cov­ery of doc­u­ments indi­cat­ing that the drug did not orig­i­nate with Chemie Grunen­thal, the post-war Ger­man chem­i­cal firm, as has always been claimed.

If, as their research sug­gests, thalido­mide was first devel­oped by sci­en­tists work­ing in wartime Ger­many, it could have impli­ca­tions for the lia­bil­i­ty of the Ger­man gov­ern­ment. So far it has giv­en com­pen­sa­tion only to Ger­man vic­tims, although the drug was dis­trib­uted in 46 coun­tries.

Thou­sands of the drug’s vic­tims are still bat­tling for increased finan­cial aid to help them cope with its lega­cy. There are 457 thalido­miders remain­ing in the UK; 2,700 in Ger­many; and a total of up to 6,000 worldwide.s

Moth­ers pre­scribed it between its launch in 1957 and 1961, when it was removed from the mar­ket, gave birth to chil­dren who lacked prop­er arms, legs, hands and feet. Some had also suf­fered brain dam­age and oth­er dis­abil­i­ties.

Dr Mar­tin John­son, direc­tor of the Thalido­mide Trust which pro­vides help for sur­viv­ing vic­tims in the UK, has writ­ten a paper detail­ing evi­dence sug­gest­ing that the drug had been devel­oped before Grunen­thal secured a patent in 1954.

The com­pa­ny has always main­tained that thalido­mide was cre­at­ed by chance in 1953 by sci­en­tists who had tried to cre­ate an anti­his­t­a­mine but end­ed up with a tran­quil­liz­er.

John­son sus­pects that it was actu­al­ly first pro­duced as a pos­si­ble anti­dote to nerve tox­ins such as sarin, which was devel­oped by Otto Ambros, a Nazi sci­en­tist who joined Grunen­thal after the war.

‘It is now appear­ing increas­ing­ly like­ly that thalido­mide was the last war crime of the Nazis,’ said John­son.

One doc­u­ment unearthed by the Thalido­mide Trust shows that Grunen­thal appar­ent­ly pur­chased the trade name of the drug — Con­ter­gan — and there­fore prob­a­bly the sub­stance itself, from a French firm, Rhone-Poulenc, which was under Nazi con­trol dur­ing the war years.

A con­fi­den­tial let­ter sent from Astra, which held the Swedish licence to dis­trib­ute thalido­mide, to its Nor­we­gian sub­sidiary in 1958 states: ‘Unfor­tu­nate­ly we can’t use the name Con­ter­gan in the Scan­di­na­vian coun­tries, since Grunen­thal obtained the name exclu­sive­ly for the Ger­man mar­ket through an agree­ment with Rhone-Poulenc.’

From 1942 onwards Rhone-Poulenc reg­is­tered 14 sim­i­lar drugs, all end­ing with the same ‘ergan’ suf­fix, a char­ac­ter­is­tic unique to the firm. Many of the drugs shared prop­er­ties with thalido­mide, such as affect­ing the ner­vous sys­tem.”

7. Joe Biden’s pol­i­cy vis a vis Covid may well be eugeni­cist in its ori­en­ta­tion. Return­ing to “nor­mal,” in most respects, but allow­ing the virus to cir­cu­late, plac­ing seniors–no longer in the workforce–at risk

We have not­ed that Biden’s social poli­cies appear to be exten­sions of his nation­al secu­ri­ty pol­i­cy. He has stat­ed that com­pet­ing with Chi­na is a pri­or­i­ty.

In that regard, trim­ming expens­es, includ­ing the rel­a­tive­ly expen­sive social pro­grams need­ed to care for the elder­ly, is appar­ent­ly on the front burn­er. 

Bot­tom line: old folks don’t work.

” . . . . ‘And the ques­tion I have is, how much death are we OK with?’ she asks. ‘Have we decid­ed this is OK? And if so, why?’ . . . . Covid-19 has always been a dis­ease of the elder­ly, defined almost more by its age skew of mor­tal­i­ty than by any of its oth­er char­ac­ter­is­tics, with risk dou­bling rough­ly every eight years and octo­ge­nar­i­ans hun­dreds of times more at risk of death than young adults. . . .”

“Endem­ic Covid-19 Is Look­ing Bru­tal” by David Wal­lace-Wells; The New York Times; 7/24/2022.

. . . . More than 300 Amer­i­cans have been dying near­ly every day for months; the num­ber is today above 400, and grow­ing.

Right now, [Dr. Trevor] Bed­ford says, around 5 per­cent of the coun­try is get­ting infect­ed with the coro­n­avirus each month and he expects that pat­tern to large­ly con­tin­ue. What would that imply death-wise, I ask? As a ball­park esti­mate, he says, going for­ward we can expect that every year, around 50 per­cent of Amer­i­cans will be infect­ed and more than 100,000 will die. . . .

. . . . A hun­dred thou­sand deaths is more than the annu­al toll of any oth­er infec­tious dis­ease and would make Covid-19 a top-10 cause of death in the coun­try — a major and nov­el cause of wide­spread death cloud­ing the Amer­i­can hori­zon with anoth­er dark lay­er of mor­bid­i­ty we had nev­er known before. It’s a few mul­ti­ples of a typ­i­cal flu sea­son and more than die each year from dia­betes, pneu­mo­nia or kid­ney dis­ease. It is what this news­pa­per once called, in an immor­tal front-page ban­ner, “an incal­cu­la­ble loss.”

How do you cal­cu­late a loss 10 times as high? How can you reck­on with that lev­el of dying, each year, going for­ward? Accord­ing to Céline Gounder, an infec­tious dis­ease epi­demi­ol­o­gist and a senior fel­low at the Kaiser Fam­i­ly Foun­da­tion, that fig­ure is actu­al­ly the low end — the ball­park, she says, runs from 100,000 to 250,000. That’s not her esti­mate of this year’s toll but of the annu­al con­tin­u­ing mor­tal­i­ty bur­den rolling for­ward indef­i­nite­ly into the future. “And the ques­tion I have is, how much death are we OK with?” she asks. “Have we decid­ed this is OK? And if so, why?” . . . .

. . . . Covid-19 has always been a dis­ease of the elder­ly, defined almost more by its age skew of mor­tal­i­ty than by any of its oth­er char­ac­ter­is­tics, with risk dou­bling rough­ly every eight years and octo­ge­nar­i­ans hun­dreds of times more at risk of death than young adults. But in a time of wide­spread vac­ci­na­tion and almost uni­ver­sal infec­tion, that gap may well expand.

[Dr. Michael] Mina com­pares the build­ing of immu­ni­ty to the learn­ing of a lan­guage. “It’s a fact of the biol­o­gy of immu­ni­ty that it’s real­ly hard to build a brand-new mem­o­ry and keep it if you’re old,” he says. “And so I do think that for quite a while our elder­ly pop­u­la­tion is going to keep hav­ing real­ly big prob­lems because they just can’t retain these new mem­o­ries.” Peo­ple exposed today, who will become 80 years old in 25 years or so, won’t have the same prob­lem, Mina says, because they will have built their immune mem­o­ry at a younger age. . . .

8. Indica­tive of Biden’s cyn­i­cism on social and eco­nom­ic pol­i­cy is his selec­tion to serve on the Social Secu­ri­ty Admin­is­tra­tion:

” . . . . Defend­ers of Social Secu­ri­ty on Tues­day urged the U.S. Sen­ate to block Pres­i­dent Joe Biden’s lit­tle-noticed nom­i­na­tion of Andrew Big­gs — an Amer­i­can Enter­prise Insti­tute senior fel­low with a his­to­ry of sup­port­ing Social Secu­ri­ty pri­va­ti­za­tion — to serve on the inde­pen­dent and bipar­ti­san Social Secu­ri­ty Advi­so­ry Board. . . . Biden was vice pres­i­dent when for­mer Pres­i­dent Barack Oba­ma pro­posed a ‘grand bar­gain’ with the GOP that would have entailed cuts to Social Secu­ri­ty. Big­gs, too, has a long record of advo­cat­ing Social Secu­ri­ty cuts. As Cun­ning­ham-Cook wrote last month, ‘For years, Big­gs has been a vocal crit­ic of expand­ed Social Secu­ri­ty and work­ers’ right to a secure, sta­ble retire­ment free from the vagaries of the stock mar­ket.’. . .”

“Biden’s Nom­i­nee for Social Secu­ri­ty Board” by Jake John­son [Com­mon Dreams]; Con­sor­tium News; 7/6/2022.

The advo­ca­cy group Social Secu­ri­ty Works is urg­ing the Sen­ate to block Andrew Big­gs’ appoint­ment by high­light­ing his role in the George W. Bush administration’s failed attempt to pri­va­tize the New Deal pro­gram in 2005.

Defend­ers of Social Secu­ri­ty on Tues­day urged the U.S. Sen­ate to block Pres­i­dent Joe Biden’s lit­tle-noticed nom­i­na­tion of Andrew Big­gs — an Amer­i­can Enter­prise Insti­tute senior fel­low with a his­to­ry of sup­port­ing Social Secu­ri­ty pri­va­ti­za­tion — to serve on the inde­pen­dent and bipar­ti­san Social Secu­ri­ty Advi­so­ry Board.

Social Secu­ri­ty Works, a pro­gres­sive advo­ca­cy group, is lead­ing the charge against Big­gs, high­light­ing his role in the George W. Bush administration’s failed attempt to pri­va­tize the New Deal pro­gram in 2005. At the time, Big­gs worked on Social Secu­ri­ty as an asso­ciate direc­tor of Bush’s Nation­al Eco­nom­ic Coun­cil.

“Andrew Big­gs has advo­cat­ed for Social Secu­ri­ty cuts through­out his career. And now, he’s been nom­i­nat­ed to over­see Social Secu­ri­ty,” Social Secu­ri­ty Works tweet­ed on Tues­day.

The group, whose pres­i­dent cur­rent­ly serves on the Social Secu­ri­ty Advi­so­ry Board (SSAB), is also shar­ing a sam­ple call script for those who wish to con­tact their rep­re­sen­ta­tives about Big­gs.

“The Sen­ate can, and must, block this ter­ri­ble nom­i­na­tion,” the orga­ni­za­tion wrote. “Please call your sen­a­tors at 202–224-3121 and tell them to vote NO on Andrew Big­gs.”

The White House announced Big­gs’ nom­i­na­tion to the SSAB in May, a move that drew lit­tle notice at the time.

Last month, The Lever‘s Matthew Cun­ning­ham-Cook called atten­tion to the president’s pick and warned it sug­gests “there could soon be a coor­di­nat­ed push in Wash­ing­ton to cut the Social Secu­ri­ty pro­gram, which pro­vides retire­ment, dis­abil­i­ty, and sur­vivor ben­e­fits to 66 mil­lion Amer­i­cans.”

While Biden vowed on the cam­paign trail to back an expan­sion of Social Secu­ri­ty, he has pre­vi­ous­ly sup­port­ed cut­ting the program’s ben­e­fits. Biden was vice pres­i­dent when for­mer Pres­i­dent Barack Oba­ma pro­posed a “grand bar­gain” with the GOP that would have entailed cuts to Social Secu­ri­ty.

Big­gs, too, has a long record of advo­cat­ing Social Secu­ri­ty cuts. As Cun­ning­ham-Cook wrote last month, “For years, Big­gs has been a vocal crit­ic of expand­ed Social Secu­ri­ty and work­ers’ right to a secure, sta­ble retire­ment free from the vagaries of the stock mar­ket.”

“He has dis­missed the retire­ment cri­sis as a non-issue and as recent­ly as 2020 blamed prob­lems with the Social Secu­ri­ty sys­tem on ‘old­er Amer­i­cans’ game of chick­en,’” he added. “While the seat on the bipar­ti­san board is by tra­di­tion assigned to a Repub­li­can, Biden could have cho­sen a mod­er­ate can­di­date — or even leaned on prece­dent to avoid the nom­i­na­tion process alto­geth­er. For­mer Pres­i­dent Don­ald Trump rou­tine­ly refused to nom­i­nate Democ­rats for seats on boards and com­mis­sions.”

Sim­mer­ing out­rage over Big­gs’ nom­i­na­tion to serve on the SSAB, which was formed in 1994 to advise the pres­i­dent and Con­gress on Social Secu­ri­ty, comes as pro­gres­sives are demand­ing an expan­sion of the program’s mod­est ben­e­fits — while Repub­li­can law­mak­ers, per usu­al, eye cuts.

Last month, Sens. Bernie Sanders (I‑Vt.) and Eliz­a­beth War­ren (D‑Mass.) led the intro­duc­tion of the Social Secu­ri­ty Expan­sion Act, which would lift the cap on income sub­ject to the Social Secu­ri­ty pay­roll tax and boost the program’s annu­al ben­e­fits by $2,400.

“At a time when half of old­er Amer­i­cans have no retire­ment sav­ings and mil­lions of senior cit­i­zens are liv­ing in pover­ty, our job is not to cut Social Secu­ri­ty,” Sanders said at the time. “Our job must be to expand Social Secu­ri­ty so that every senior cit­i­zen in Amer­i­ca can retire with the dig­ni­ty they deserve and every per­son with a dis­abil­i­ty can live with the secu­ri­ty they need.”

Discussion

7 comments for “FTR#1258 Pandemics, Inc., Part 8: Covid Update”

  1. Every­one has one choice when it comes to the COVID pan­dem­ic: take the mRNA vac­cines or not. That’s obvi­ous­ly not true. There are plen­ty of non-mRNA COVID vac­cines cur­rent­ly avail­able. But it’s hard to ignore how the under­ly­ing mes­sage to the pub­lic in the US about COVID vac­cines has large­ly been to take the mRNA vac­cines or not get vac­ci­nat­ed at all. The non-mRNA vac­cines have effec­tive­ly been ‘unper­son­ed’ in the cov­er­age of the pan­dem­ic.

    That’s been the case from the very begin­ning of the pan­dem­ic. But it may have been tak­en to a new absurd lev­el in the fol­low­ing arti­cle in the Atlantic about a rare side-effect from mRNA recent­ly report­ed: A Bel­gian immu­nol­o­gist long involved in study­ing new med­i­cines, includ­ing the mRNA vac­cines, had to report an unfor­tu­nate find­ing. And a very per­son­al find­ing at that. Short­ly after get­ting an mRNA boost­er, Gold­man’s case of lym­phoma grew dra­mat­i­cal­ly worse right around the spot of the injec­tion.

    And while Gold­man is just a sin­gle case, the data points were quite com­pelling. Gold­man’s angioim­munoblas­tic T‑cell lym­phoma affects fol­lic­u­lar helper T cells, and research has already found that mRNA vac­cines are par­tic­u­lar­ly effec­tive at pro­vid­ing an extra ‘oomph’ to the body’s fol­lic­u­lar helper T cells. Also, Gold­man’s tumor has a muta­tion known to pre­dis­pose T‑cells to go rogue.

    But that research show­ing mRNA vac­cine specif­i­cal­ly pro­vide an extra ‘oomph’ to T‑cells also poten­tial­ly relates to that fas­ci­nat­ing Sep­tem­ber 2016 STAT News arti­cle that described how Mod­er­na had shift­ed its focus from mRNA ther­a­peu­tics — which require numer­ous shots over years — to mRNA vac­cines. It was seen as as dis­ap­point­ment by indus­try observers and sign that Mod­er­na was run­ning into undis­closed set­backs involv­ing side effects trig­gered by the lipid nanopar­ti­cle (LNP) deliv­ery vehi­cle for the mRNA. But as we saw, Mod­er­na was insist­ing at the time that it was expe­ri­enc­ing no such set backs. And yet observers were just forced to take their word because the com­pa­ny was being so secre­tive and releas­ing almost no infor­ma­tion about its inter­nal tri­als. It was one of the high­ly con­ve­nient aspects of the whole mRNA vac­cine sit­u­a­tion: the side effects from the LNP deliv­ery vehi­cle just might be desir­able and have an adju­vant-like effect in the con­text of a vac­cine if those side effects end up revving up the immune sys­tem. So it should­n’t be par­tic­u­lar­ly sur­pris­ing when we learn that there might be rare side effects involv­ing an over­ly-revved-up immune sys­tem. The extra immuno­log­i­cal ‘oomph’ from the mRNA vac­cines was tout­ed as a sell­ing point, after all.

    So we have to ask: is the extra immuno­log­i­cal ‘oomph’ tar­get­ing fol­lic­u­lar ‘helper’ T‑cells trig­gered specif­i­cal­ly by mRNA vac­cines — and which may have exac­er­bat­ed Gold­man’s lym­phoma — at all relat­ed to the side-effects observed by the LNP deliv­ery vehi­cles? It’s the kind of ques­tion we had bet­ter hope researchers are ask­ing. But that brings us to anoth­er part of this sto­ry: as the arti­cle describes, the med­ical estab­lish­ment is basi­cal­ly inca­pable of real­ly study­ing these rel­a­tive­ly rare side effects. If some­thing can’t be sta­tis­ti­cal­ly con­firmed with a ran­dom­ized con­trolled tri­al (RCT), the med­ical estab­lish­ment is high­ly prone to ignore it. And rare side-effects are very often going to be too rare to set up an RCT.

    But then there’s the fact that immuno­log­i­cal dis­or­ders can man­i­fest in all sorts of ways. We should­n’t expect just a sin­gle type of symp­tom to show up if, for exam­ple, T‑cells are being turned rogue. So even if rare side-effects have a com­mon under­ly­ing immuno­log­i­cal cause we’re going to be poised to miss it.

    But when there’s plen­ty of non-mRNA COVID vac­cine options avail­able, the ques­tion of whether or not the risks of the mRNA vac­cines for lym­phoma patients are worth the cost/benefit trade­offs in the face of unknown risks is kind of beside the point. Just give the can­cer patients one of the non-mRNA vac­cines instead. And that brings us to the tru­ly bizarre aspect of this sto­ry. Because as we’re going to see, while Michel Gold­man appears to be gen­uine­ly torn as to whether or not he’s will­ing to take a sec­ond mRNA COVID boost­er shoot after the expe­ri­ence he had with the first shot, he does­n’t appear to have con­sid­ered at all the pos­si­bil­i­ty of tak­ing one of the non-mRNA vac­cines. Like it just does­n’t even come up as an option in the entire arti­cle.

    It’s the lat­est exam­ple of this bizarre hyper-pref­er­ence for what are still exper­i­men­tal mRNA vac­cines. We’ve already seen how the mRNA boost­ers are being approved based on mouse tri­al data alone. We also saw how the FDA issued a warn­ing about the John­son & John­son vac­cine back in May for a very rare side effect despite the fact that those vac­cines appeared to actu­al­ly have the best effi­ca­cy against vari­ants. And as we’re going to see the arti­cle, even Gold­man him­self was com­ment­ing on how the AstraZeneca vac­cine side-effects were far less of a risk than the risk of COVID itself. Gold­man, who resides in Europe, pre­sum­ably has access to that vac­cine. But he’s not tak­ing it. It’s mRNA vac­cines or noth­ing for Michel Gold­man. For rea­sons that remain entire­ly unex­plained to this day:

    The Atlantic

    Did a Famous Doctor’s COVID Shot Make His Can­cer Worse?

    A life­long pro­mot­er of vac­cines sus­pects he might be the rare, unfor­tu­nate excep­tion.

    By Rox­anne Kham­si
    Sep­tem­ber 24, 2022, 8 AM ET

    On Sep­tem­ber 22 of last year, Michel Gold­man, a Bel­gian immu­nol­o­gist and one of Europe’s best-known cham­pi­ons of med­ical research, walked into a clin­ic near his house, rolled up his sleeve, and had a boost­er shot deliv­ered to his arm. He knew he’d need it more than most.

    Just a few weeks ear­li­er, Michel, 67, had been to see his younger broth­er, Serge, the head of nuclear med­i­cine at the hos­pi­tal of the Uni­ver­sité Libre de Brux­elles, where both men are pro­fes­sors. Michel was hav­ing night sweats, and he could feel swollen lymph nodes in his neck, so his broth­er brought him in for a full-body CT scan. When the images came through to Serge’s com­put­er they revealed a smat­ter­ing of inky spots, bunched near Michel’s left armpit and run­ning up along his neck. It was can­cer of the immune system—lymphoma.

    Giv­en his own area of exper­tise, Michel under­stood this meant he’d soon be immuno­com­pro­mised by chemother­a­py. With anoth­er win­ter on the way—and per­haps anoth­er wave of SARS-CoV­‑2 infections—that meant he had just a nar­row win­dow of oppor­tu­ni­ty in which his body would respond in full to COVID vac­ci­na­tion. Hav­ing received two dos­es of Pfiz­er the pri­or spring, Michel quick­ly went to get his third. If he was about to spend months absorb­ing poi­son as he tried to beat a dead­ly can­cer, at least he’d have the most pro­tec­tion pos­si­ble from the pan­dem­ic.

    With­in a few days, though, Michel was some­how feel­ing even worse. His night sweats got much more intense, and he found himself—quite out of character—taking after­noon naps. Most wor­ry­ing­ly, his lymph nodes were even more swollen than before. He con­ferred with Serge again, and they set up anoth­er body scan for Sep­tem­ber 30, six days before Michel was sched­uled to start his can­cer treat­ment. Once again he sat in the radi­ol­o­gy wait­ing room while his broth­er wait­ed for the pic­tures to appear on his com­put­er.

    Serge’s bushy eye­brows fur­rowed when he spoke with Michel after hav­ing seen the scans. (“I will always remem­ber his face, it was just incred­i­ble,” Michel told me.) The pic­tures showed a brand-new bar­rage of can­cer lesions—so many spots that it looked like some­one had set off fire­works inside Michel’s body. More than that, the lesions were now promi­nent on both sides of the body, with new clus­ters bloom­ing in Michel’s right armpit in par­tic­u­lar, and along the right side of his neck.

    When Michel’s hema­tol­o­gist saw the scan, she told him to report direct­ly to the near­est hos­pi­tal phar­ma­cy. He’d have to start on steroid pills right away, she told him. Such a swift pro­gres­sion for lym­phoma in just three weeks was high­ly unusu­al, and he could not risk wait­ing a sin­gle day longer.

    As he fol­lowed these instruc­tions, Michel felt a gnaw­ing wor­ry that his COVID boost­er shot had some­how made him sick­er. His broth­er was har­bor­ing a sim­i­lar con­cern. The asym­met­ri­cal clus­ter of can­cer­ous nodes around Michel’s left armpit on the ini­tial scan had already seemed “a bit dis­turb­ing,” as his broth­er said; espe­cial­ly giv­en that Michel’s first two dos­es of vac­cine had been deliv­ered on that side. Now he’d had a boost­er shot in the oth­er arm, and the cancer’s asym­me­try was flipped.

    The broth­ers knew this might be just an eerie coin­ci­dence. But they couldn’t shake the feel­ing that Michel had expe­ri­enced what would be a very rare yet life-threat­en­ing side effect of COVID vac­ci­na­tion. For a doc­tor who had spent four decades study­ing and advo­cat­ing for new med­i­cines, that feel­ing would unfold into many months of delib­er­a­tion and self-doubt. Michel used to run an insti­tute for vac­cine-tech­nol­o­gy research, and he’s spo­ken out to reas­sure the pub­lic about the safe­ty of the COVID vac­cines, and of the mRNA vac­cines in par­tic­u­lar. In Decem­ber 2020, he told an inter­view­er that “if there was a real prob­lem with the tech­nol­o­gy, we’d have seen it before now for sure.” His “main con­cern,” he con­tin­ued, was that peo­ple would use the mere pos­si­bil­i­ty of side effects “as an argu­ment not to be vac­ci­nat­ed.”

    But now that pos­si­bil­i­ty appeared to be splat­tered all across his med­ical charts. Michel Gold­man, cham­pi­on of the mRNA vac­cines, sus­pect­ed that he was their unlucky vic­tim.

    I hap­pened to speak with Michel by phone in April 2021, months before his can­cer diag­no­sis. I’d called him to dis­cuss anoth­er poten­tial side effect of COVID vac­ci­na­tion, one asso­ci­at­ed in par­tic­u­lar with the shot made by AstraZeneca. By that point, 220 peo­ple who’d received that vac­cine had devel­oped an unusual—and very dangerous—blood-clotting syn­drome, which was char­ac­ter­ized by an atyp­i­cal low platelet count. At least sev­en peo­ple in the U.K. alone had died of the com­pli­ca­tion. Michel patient­ly laid out the dif­fer­ent mech­a­nisms that might explain this strange con­di­tion. But he was quick to add that the mRNA COVID vac­cines were built in a way that could mit­i­gate the risk of this par­tic­u­lar prob­lem.

    Michel cur­rent­ly leads the I3h insti­tute, a uni­ver­si­ty hub aimed at assist­ing in drug-design projects; in an ear­li­er post­ing, he head­ed a $2 bil­lion Euro­pean endeav­or to accel­er­ate the research of new med­i­cines. As such, he’s spent many years attend­ing to the pos­si­ble risks—even tiny ones—of nov­el med­ical treat­ments. He has raised aware­ness about the iron over­load that used to afflict dial­y­sis patients before the advent of a drug known as ery­thro­poi­etin, for exam­ple; and looked for signs of “cytokine storms” in kid­ney-trans­plant recip­i­ents who received mon­o­clon­al-anti­body treat­ments. So when a pletho­ra of new vac­cines for COVID emerged in the first year of the pan­dem­ic, he was watch­ing very close­ly.

    When we talked about the poten­tial side effects of the AstraZeneca vac­cine last year, Michel made it clear that, in the big pic­ture, any chance of seri­ous com­pli­ca­tions from the shots would be orders of mag­ni­tude small­er than the chance of com­pli­ca­tions from the pan­dem­ic ill­ness itself. If COVID vac­cines caused clot­ting dis­or­ders or myocardi­tis in a tiny per­cent­age of those who received them, he assured me, COVID would lead to stroke or heart inflam­ma­tion in a much larg­er group.

    The risks and ben­e­fits for each vac­cine should be weighed against each oth­er, he con­tin­ued. If AstraZeneca were the only option, then its pro­tec­tion might be worth the very small risk of devel­op­ing a rare blood dis­or­der. But giv­en the avail­abil­i­ty of Pfiz­er, Mod­er­na, and oth­er COVID vac­cines, many peo­ple could opt for a safer alter­na­tive.

    Now that risk-ben­e­fit cal­cu­la­tion has been thrust upon him in a per­son­al and ter­ri­fy­ing way. By the time we spoke again, he’d become a can­cer patient who sus­pect­ed that his mRNA vac­cine might have made things worse. Michel is reserved by nature, prone to mak­ing mat­ter-of-fact remarks rather than emo­tive mus­ings. In this case, I found him more guard­ed than ever, and I could tell he’d strug­gled over how he should describe his own experience—or, indeed, whether he should even be describ­ing it at all. Per­haps his hypoth­e­sis was wrong, and the course of his can­cer had had noth­ing to do with the shots. Or maybe the can­cer and the mRNA vac­cine were con­nect­ed, but the risk of get­ting immu­nized was still just a tiny speck beside the ben­e­fits. Apply­ing the same log­ic that he’d used before, he decid­ed it made sense to go pub­lic with this the­o­ry. If oth­er peo­ple with the same lym­phoma felt the need to hedge their bets, they might con­sid­er hold­ing off on the Pfiz­er and Mod­er­na shots.

    Michel knew that by speak­ing out about anoth­er poten­tial rare effect—especially with­out hard proof—he’d be intro­duc­ing a dif­fer­ent kind of risk. Recent years had already seen a rise in anti-vac­cine dis­in­for­ma­tion, and pro­test­ers have thrown men­stru­al blood at state leg­is­la­tors and issued death threats to pub­lic-health offi­cials. Fear­mon­gers have made the prob­lem worse by cit­ing scary-sound­ing data from the Vac­cine Adverse Event Report­ing Sys­tem, a U.S. gov­ern­ment data­base of pos­si­ble side effects from immu­niza­tions, with insuf­fi­cient con­text. In Europe, French police used tear gas to dis­perse anti-vac­cine pro­test­ers who were aim­ing fire­works at offi­cers in July of 2021; a vac­ci­na­tion cen­ter was set ablaze in Poland a few weeks lat­er. Michel was well aware of all this trend; in fact, he’d been sound­ing the alarm about the spread of vac­cine mis­in­for­ma­tion online before the. If he shared his own expe­ri­ence of can­cer, might that make the prob­lem worse?

    This was not a rea­son to remain silent, Michel even­tu­al­ly decid­ed. It was a rea­son to speak care­ful­ly.

    ...

    Michel’s can­cer was the kind that attacks the body’s T cells, which coor­di­nate the immune response to invad­ing pathogens. T‑cell lym­phomas come in rough­ly 30 dif­fer­ent sub­types; Michel’s, known as angioim­munoblas­tic T‑cell lym­phoma, affects what are called fol­lic­u­lar helper T cells, which hang out in the ton­sils and the lymph nodes, among oth­er tis­sues.. Fol­lic­u­lar helper T cells serve a cru­cial role in the cas­cade of events to pro­tect the body after dan­ger­ous invaders have arrived. That process begins with den­drit­ic cells, which iden­ti­fy a virus or oth­er pathogen and present exam­ples of it to the rest of the immune sys­tem. The helper T cells do just as their name sug­gests: They help pass that mes­sage along to B cells, which end up mak­ing pro­tec­tive anti­bod­ies against the virus.

    Michel had recent­ly learned that mRNA vac­cines, such as the Pfiz­er shots he had received, are espe­cial­ly effec­tive at gen­er­at­ing that mes­sage, and spurring its pas­sage through the helper T cells. Some researchers argue that the COVID vac­cines from Pfiz­er and Mod­er­na have been more pro­tec­tive than oth­ers for exact­ly this rea­son: They rev up those cells with extra oomph. Now Michel began to won­der whether that oomph could, in ultra­rare cas­es, turn out to be a lia­bil­i­ty. Per­haps the shots gave such a jolt to his helper T cells that they went berserk. If they were prone to form­ing tumors, or if they were already can­cer­ous, then over­stim­u­la­tion could have made the prob­lem even worse.

    As the days went by, Michel found oth­er clues sug­gest­ing that the link was real, and that the mRNA vac­cines might be risky for a spe­cif­ic sub­set of the pop­u­la­tion. He learned that body scans of some of those who get vac­cines, includ­ing can­cer patients, have shown height­ened activ­i­ty in the lymph nodes near the armpit on the side where the shot was received. He also came across anoth­er, very impor­tant clue. In 2018, a team of researchers based at Colum­bia University’s Insti­tute for Can­cer Genet­ics had pub­lished an intrigu­ing study using mice with a pair of gene muta­tions that, when they co-occur, pre­dis­pose T cells to go rogue. (Michel’s tumor, which had been sequenced by this point, showed the same two muta­tions.) When these mice were inject­ed with sheep red-blood cells—as an exper­i­men­tal stand-in for invad­ing microbes—the ani­mals devel­oped the sub­type of lym­phoma that was diag­nosed in Michel.

    Now Michel had a the­o­ry to explain the bleak coin­ci­dence that had befall­en him. Serge agreed that it made sense. The broth­ers had co-writ­ten research papers in the past, includ­ing ones on the use of stem cells for heart repair and den­drit­ic-cell vac­cines for can­cer. It was time for them to write anoth­er.

    On Octo­ber 20 of last year, Hans-Georg Eich­ler, a clin­i­cal phar­ma­col­o­gist and for­mer senior med­ical offi­cer for the Euro­pean Med­i­cines Agency, opened up his email to find a mes­sage from Michel. The two have known each oth­er for more than a decade. “I hope that you are well,” the mes­sage start­ed, “which is not real­ly my case ...” Michel had past­ed in a link to a med­ical report, not yet pub­lished. “I am curi­ous to hear your thoughts,” he wrote.

    The paper, titled “Rapid Pro­gres­sion of Angioim­munoblas­tic T Cell Lym­phoma Fol­low­ing BNT162b2 mRNA Vac­cine Boost­er Shot” and cred­it­ed to Serge Gold­man, Michel Gold­man, and six of their Bel­gian col­leagues, would run in the jour­nal Fron­tiers in Med­i­cine a few weeks lat­er. (Michel is that journal’s edi­tor in chief; he recused him­self from the process of edit­ing and peer review.) It begins by describ­ing “a 66-year-old man with no sig­nif­i­cant med­ical his­to­ry” who had been diag­nosed with lym­phoma that wors­ened fol­low­ing a boost­er dose of COVID-19 vac­cine. The Gold­mans’ unusu­al con­nec­tion to the data—the fact that the 66-year-old man in ques­tion was Michel—comes across oblique­ly in the text. An ethics state­ment, print­ed at the end of the case report, includes the line: “Being one of the authors, the patient con­sent­ed to the pub­li­ca­tion.”

    Eich­ler, who had close­ly fol­lowed the furor over vac­cine-asso­ci­at­ed blood-clot dis­or­ders the pre­vi­ous spring, replied that evening: “I have read the paper and am very impressed … It is the most respon­si­ble and coura­geous thing you could do under the worst pos­si­ble cir­cum­stances.”

    “I would say that 95 per­cent of the reac­tions were extreme­ly friend­ly,” Michel told me lat­er. But as he’d feared, anti-vac­cine activists picked up on the sto­ry. “The lymph nodes of those who have tak­en these shots are explod­ing, bur­geon­ing, and bulging with this tox­ic bioweapon,” a right-wing influ­encer named Jane Ruby wrote on Telegram beneath a screen­shot of Michel’s CT scans, which had appeared in his pub­lished paper (and are repro­duced in this arti­cle). “LYMPHOMA — That’s right… Can­cer of the lym­phat­ic sys­tem … STOP THIS FROM GETTING INTO BABIES AND CHILDREN!!!!!” Ruby’s claims were ampli­fied on Nat­ur­al News, among oth­er anti-vac­ci­na­tion sites where, again, the very images that Michel’s broth­er had used to diag­nose his ill­ness were pre­sent­ed as shock­ing evi­dence of vaccination’s dan­gers. “PHOTOS: LYMPHOMA CANCER EXPLODING IN THE BOOSTED,” one web­site said.

    When I told Michel about these online posts, he shook his head in dis­ap­point­ment. “They’re look­ing for any­thing to sup­port their crazy vision,” he said. “It makes me sad about the world in which we are liv­ing.” That’s not to say he was sur­prised. Michel knew, for instance, that med­ical experts have dis­pelled false rumors about vac­cines infect­ing peo­ple with COVID-19. He told me that he’d obsessed over get­ting the tone of the man­u­script exact­ly right, so as not to fuel vac­cine skep­ti­cism. He was care­ful, for exam­ple, to describe the vac­cine as pos­si­bly “induc­ing” the “pro­gres­sion” of his cancer—rather than “caus­ing” it to sur­face. “I spent hours and hours,” he said. “I’ve nev­er spent so much time on details in a paper.”

    Extreme­ly rare cas­es like Michel’s cre­ate a tricky ter­rain for sci­ence com­mu­ni­ca­tion. Even a clin­i­cal tri­al with thou­sands of par­tic­i­pants might nev­er turn up a sin­gle case of some­one’s can­cer wors­en­ing after vac­ci­na­tion. In that con­text, experts can’t assign a sta­tis­ti­cal esti­mate of the risk across the wider pop­u­la­tion. Sci­ence jour­nal­ists may be wary of report­ing on the sto­ry for that rea­son. In fact, when Michel first told me about his can­cer and about the paper he’d writ­ten with his broth­er, I said that I couldn’t write about it. I was wor­ried that some read­ers would mis­in­ter­pret my arti­cle, and mis­tak­en­ly see it as a rea­son not to get vac­ci­nat­ed. As I write this, I’m still con­cerned that you might do exact­ly that.

    But the sci­en­tif­ic lit­er­a­ture is sprin­kled with odd cas­es like Michel’s that have puz­zled doc­tors. The Gold­mans’ paper fol­lows ear­li­er iso­lat­ed reports sug­gest­ing a pos­si­ble link between COVID-19 vac­ci­na­tion and lym­phoma. Aaron Man­gold, who heads the divi­sion of clin­i­cal der­ma­tol­ogy at the Mayo Clin­ic in Ari­zona, co-authored a paper pub­lished in May 2021 about a patient whose rare skin lym­phoma recurred after his ini­tial Pfiz­er shot. The tumor­ous ulcer appeared in the armpit of the same arm in which the man had received the injec­tion, and then regressed spon­ta­neous­ly. A sec­ond shot of the vac­cine, deliv­ered three weeks lat­er, pro­duced no fur­ther lesions, Man­gold told me, and the whole ordeal could have sim­ply been a coin­ci­dence. He felt that he’d been “thread­ing the nee­dle” to go pub­lic with the case report giv­en that uncer­tain­ty.

    Ladan Zand, a nephrol­o­gist at the Mayo Clin­ic in Rochester, Min­neso­ta, faced the same conun­drum when she co-authored a paper last year detail­ing five patients who had a relapse of kid­ney dis­ease fol­low­ing mRNA COVID vac­ci­na­tion. Her team also doc­u­ment­ed eight patients who were new­ly diag­nosed with the dis­ease, known as glomeru­lonephri­tis, after receiv­ing the shot. But Zand cau­tions that those patients might have had under­ly­ing kid­ney dis­ease and not been aware of it. Peo­ple infect­ed with the nov­el coro­n­avirus also show high­er rates of kid­ney-func­tion decline over time. “I spend half of my vis­its now ask­ing patients to get vac­ci­nat­ed,” she said. “If you were to com­pare the risks and ben­e­fits, the ben­e­fits of the vac­cine way out­weigh the risk of rare enti­ties that, for the most part, seem to be self-lim­it­ing.”

    William Mur­phy, an immu­nol­o­gist at UC Davis, told me that Michel’s before-and-after CT scans were fas­ci­nat­ing in the con­text of the mouse study from Colum­bia. The cancer’s behav­ior cer­tain­ly appeared to be relat­ed to the vac­cine, he said, “giv­en the huge dif­fer­ence in the scans of the tumor pro­gres­sion in a very short peri­od of time.” But one can’t be cer­tain, how­ev­er strik­ing the data. It’s just a case report, he added—one patient.

    The Gold­mans’ paper, for its part, notes that it would be “pre­ma­ture” to extrap­o­late the find­ings from Michel to oth­er patients with the same kind of can­cer, and that the link, even if it were proved, should not dis­cour­age gen­er­al uptake of “much-need­ed vac­cines.” An unusu­al para­graph tacked onto the bot­tom of the arti­cle under­scores the point. Marked “Patient Per­spec­tive,” and writ­ten in the third per­son, it notes that Michel him­self “remains con­vinced that mRNA vac­cines rep­re­sent very effi­cient prod­ucts with a favor­able ben­e­fit-risk ratio,” and that he hopes the report will encour­age fur­ther research.

    In mid-Feb­ru­ary, Michel spiked a sud­den fever. COVID had final­ly caught up with him.

    Giv­en that he was immuno­com­pro­mised by six rounds of can­cer chemother­a­py, Michel knew that his doc­tors would need to act quick­ly. He soon received an infu­sion of the mon­o­clon­al-anti­body drug sotro­vimab, and man­aged to recov­er with­out inci­dent; his lymph nodes stayed bless­ed­ly qui­et, and there was no resur­gence of his can­cer. Now he’s eli­gi­ble for a sec­ond boost­er shot, but he’s not sure whether he should take it. “I don’t know what I will do,” he said.

    Would anoth­er dose of the vac­cine cause anoth­er round of can­cer lesions? Michel and the sci­en­tists who have been in touch with him are still mulling the evi­dence about whether his orig­i­nal can­cer flare was sim­ply a fluke. Steven Hor­witz, a med­ical oncol­o­gist at Memo­r­i­al Sloan Ket­ter­ing who focus­es on the care of patients with lym­phoma, has looked more close­ly at vac­cine side effects since hear­ing about Michel’s case, and feels reas­sured by what he’s found. “Of our patients who received mRNA COVID vac­cines, we have not seen any clear­ly relat­ed and doc­u­ment­ed relaps­es or pro­gres­sions,” he told me via email. Mean­while, lym­phomas and the treat­ments giv­en for them can weak­en the immune sys­tem, putting affect­ed patients at high­er risk of severe COVID-19 if infect­ed. “Vac­ci­na­tion remains the most effec­tive way to mit­i­gate that risk,” he said.

    I reached out to the mak­ers of the mRNA COVID vac­cines to ask about Michel’s case. A rep­re­sen­ta­tive for Pfiz­er not­ed that the com­pa­ny takes such reports “very seri­ous­ly” but that, “to date, there has been no iden­ti­fied cor­re­la­tion between the vac­cine and can­cer.” Moderna’s chief med­ical offi­cer, Paul Bur­ton, told me that the com­pa­ny keeps care­ful track of safe­ty data and has not found any rela­tion­ship between vac­ci­na­tion and lym­phoma. He also point­ed to the case of a 61-year-old woman with can­cer of the sali­vary gland whose tumor shrank to about one-quar­ter of its orig­i­nal size in the month after she received a sec­ond dose of the Mod­er­na vac­cine. “Now, did it real­ly regress because the per­son got a mes­sen­ger RNA vac­cine?” he asked. “I don’t know. I think biol­o­gy is tru­ly a remark­able thing.”

    While Michel remains unsure about his fourth shot, he has con­tin­ued to be out­spo­ken on the ben­e­fits of vac­ci­na­tion over­all, and often speaks to Bel­gian media on the top­ic. At the same time, he has become a stronger advo­cate for broad­er track­ing of adverse events from vaccines—an endeav­or he and oth­ers in drug devel­op­ment call “phar­ma­covig­i­lance.” “We need to make sure that some phar­ma­covig­i­lance pro­grams are pow­ered to detect very, very rare side effects,” Michel told me. Eich­ler, who was involved in drug reg­u­la­tion for the Euro­pean Med­i­cines Agency, said that while some doc­tors may be “afi­ciona­dos” of ran­dom­ized con­trolled tri­als as the only valid source of med­ical evi­dence, oth­er types of infor­ma­tion are need­ed. Michel’s case shows why: You’ve got a patient “who is a pro­fes­sor of med­i­cine, who expe­ri­ences the side effects and says, ‘Okay, this must be a side effect,’” Eich­ler said. That “rings the bells. Could Michel have ever come up in an RCT? My answer is prob­a­bly not.”

    ...

    Around the time of his Feb­ru­ary fol­low-up, Michel received a mes­sage from a doc­tor who had read his self-ref­er­en­tial case report. The doctor’s moth­er had been diag­nosed with the same sub­type of lym­phoma that Michel has fol­low­ing a COVID boost­er shot. More recent­ly, he got an email from a woman whose sis­ter had been vac­ci­nat­ed and received that diag­no­sis the fol­low­ing month. Again, these could be coin­ci­dences. Or maybe they are the sec­ond and third data points in a grow­ing set. The pos­si­ble con­nec­tion between Michel’s lym­phoma flare and his COVID-19 vac­ci­na­tion occu­pies much of his think­ing these days. “If it exists, it must be very rare,” he said. But he doesn’t regret going pub­lic with his case. “I’m still con­vinced it was the right thing to do.”

    ———–

    “Did a Famous Doctor’s COVID Shot Make His Can­cer Worse?” By Rox­anne Kham­si; The Atlantic; 09/24/2022

    “As he fol­lowed these instruc­tions, Michel felt a gnaw­ing wor­ry that his COVID boost­er shot had some­how made him sick­er. His broth­er was har­bor­ing a sim­i­lar con­cern. The asym­met­ri­cal clus­ter of can­cer­ous nodes around Michel’s left armpit on the ini­tial scan had already seemed “a bit dis­turb­ing,” as his broth­er said; espe­cial­ly giv­en that Michel’s first two dos­es of vac­cine had been deliv­ered on that side. Now he’d had a boost­er shot in the oth­er arm, and the cancer’s asym­me­try was flipped.”

    It was cause-and-effect hypoth­e­sis that was hard ignore: Michel Gold­man’s lym­phoma got dra­mat­i­cal­ly worse almost imme­di­ate­ly after get­ting the shot. But that was just the start of the evi­dence. The dots were thee to con­nect: Gold­man’s angioim­munoblas­tic T‑cell lym­phoma affects fol­lic­u­lar helper T cells, and research has already found that mRNA vac­cines are par­tic­u­lar­ly effec­tive at pro­vid­ing an extra ‘oomph’ to the body’s fol­lic­u­lar helper T cells. And Gold­man’s tumor has a muta­tion known to pre­dis­pose T‑cells to go rogue. Gold­man’s cas­es is only one data point, but a pret­ty com­pelling data point.

    And again, recall that fas­ci­nat­ing Sep­tem­ber 2016 STAT News arti­cle that described how Mod­er­na had shift­ed its focus from mRNA ther­a­peu­tics — which require numer­ous shots over years — to mRNA vac­cines. It was seen as as dis­ap­point­ment by indus­try observers and sign that Mod­er­na was run­ning into undis­closed set­backs involv­ing side effects trig­gered by the lipid nanopar­ti­cle (LNP) deliv­ery vehi­cle for the mRNA. But as we saw, Mod­er­na was insist­ing at the time that it was expe­ri­enc­ing no such set backs. And yet observers were just forced to take their word because the com­pa­ny was being so secre­tive and releas­ing almost no infor­ma­tion about its inter­nal tri­als. It was one of the high­ly con­ve­nient aspects of the whole mRNA vac­cine sit­u­a­tion: the side effects from the LNP deliv­ery vehi­cle just might be desir­able and have an adju­vant-like effect in the con­text of a vac­cine if those side effects end up revving up the immune sys­tem. So it should­n’t be par­tic­u­lar­ly sur­pris­ing when we learn that there might be rare side effects involv­ing an over­ly-revved-up immune sys­tem. The extra immuno­log­i­cal ‘oomph’ from the mRNA vac­cines was tout­ed as a sell­ing point, after all:

    ...
    Michel’s can­cer was the kind that attacks the body’s T cells, which coor­di­nate the immune response to invad­ing pathogens. T‑cell lym­phomas come in rough­ly 30 dif­fer­ent sub­types; Michel’s, known as angioim­munoblas­tic T‑cell lym­phoma, affects what are called fol­lic­u­lar helper T cells, which hang out in the ton­sils and the lymph nodes, among oth­er tis­sues.. Fol­lic­u­lar helper T cells serve a cru­cial role in the cas­cade of events to pro­tect the body after dan­ger­ous invaders have arrived. That process begins with den­drit­ic cells, which iden­ti­fy a virus or oth­er pathogen and present exam­ples of it to the rest of the immune sys­tem. The helper T cells do just as their name sug­gests: They help pass that mes­sage along to B cells, which end up mak­ing pro­tec­tive anti­bod­ies against the virus.

    Michel had recent­ly learned that mRNA vac­cines, such as the Pfiz­er shots he had received, are espe­cial­ly effec­tive at gen­er­at­ing that mes­sage, and spurring its pas­sage through the helper T cells. Some researchers argue that the COVID vac­cines from Pfiz­er and Mod­er­na have been more pro­tec­tive than oth­ers for exact­ly this rea­son: They rev up those cells with extra oomph. Now Michel began to won­der whether that oomph could, in ultra­rare cas­es, turn out to be a lia­bil­i­ty. Per­haps the shots gave such a jolt to his helper T cells that they went berserk. If they were prone to form­ing tumors, or if they were already can­cer­ous, then over­stim­u­la­tion could have made the prob­lem even worse.

    As the days went by, Michel found oth­er clues sug­gest­ing that the link was real, and that the mRNA vac­cines might be risky for a spe­cif­ic sub­set of the pop­u­la­tion. He learned that body scans of some of those who get vac­cines, includ­ing can­cer patients, have shown height­ened activ­i­ty in the lymph nodes near the armpit on the side where the shot was received. He also came across anoth­er, very impor­tant clue. In 2018, a team of researchers based at Colum­bia University’s Insti­tute for Can­cer Genet­ics had pub­lished an intrigu­ing study using mice with a pair of gene muta­tions that, when they co-occur, pre­dis­pose T cells to go rogue. (Michel’s tumor, which had been sequenced by this point, showed the same two muta­tions.) When these mice were inject­ed with sheep red-blood cells—as an exper­i­men­tal stand-in for invad­ing microbes—the ani­mals devel­oped the sub­type of lym­phoma that was diag­nosed in Michel.

    Now Michel had a the­o­ry to explain the bleak coin­ci­dence that had befall­en him. Serge agreed that it made sense. The broth­ers had co-writ­ten research papers in the past, includ­ing ones on the use of stem cells for heart repair and den­drit­ic-cell vac­cines for can­cer. It was time for them to write anoth­er.
    ...

    And yet, as this arti­cle describes, the med­ical estab­lish­ment does­n’t seem to be very well equipped for iden­ti­fy­ing and hon­ing in on these kinds of rare events. Even reporters are wary of report­ing on such events unless they can be sta­tis­ti­cal­ly estab­lished across a larg­er patient pop­u­la­tion which sim­ply may not be pos­si­ble for a lot of rare con­di­tions. That’s part of the sto­ry here: risks that can’t be stud­ied via a ran­dom­ized-con­trolled clin­i­cal tri­als (RCTs) are sys­tem­at­i­cal­ly ignored. And yet, if mRNA vac­cines are poten­tial­ly caus­ing immune sys­tems to go hay­wire in some patients, we can’t expect that to man­i­fest as a sin­gle dis­ease. Out of con­trol immune sys­tems man­i­fest in all sorts of ways. So you could have a shared under­ly­ing cause man­i­fest­ing as all sorts of dif­fer­ent rare events that we sys­tem­at­i­cal­ly over­look:

    ...

    Extreme­ly rare cas­es like Michel’s cre­ate a tricky ter­rain for sci­ence com­mu­ni­ca­tion. Even a clin­i­cal tri­al with thou­sands of par­tic­i­pants might nev­er turn up a sin­gle case of some­one’s can­cer wors­en­ing after vac­ci­na­tion. In that con­text, experts can’t assign a sta­tis­ti­cal esti­mate of the risk across the wider pop­u­la­tion. Sci­ence jour­nal­ists may be wary of report­ing on the sto­ry for that rea­son. In fact, when Michel first told me about his can­cer and about the paper he’d writ­ten with his broth­er, I said that I couldn’t write about it. I was wor­ried that some read­ers would mis­in­ter­pret my arti­cle, and mis­tak­en­ly see it as a rea­son not to get vac­ci­nat­ed. As I write this, I’m still con­cerned that you might do exact­ly that.

    But the sci­en­tif­ic lit­er­a­ture is sprin­kled with odd cas­es like Michel’s that have puz­zled doc­tors. The Gold­mans’ paper fol­lows ear­li­er iso­lat­ed reports sug­gest­ing a pos­si­ble link between COVID-19 vac­ci­na­tion and lym­phoma. Aaron Man­gold, who heads the divi­sion of clin­i­cal der­ma­tol­ogy at the Mayo Clin­ic in Ari­zona, co-authored a paper pub­lished in May 2021 about a patient whose rare skin lym­phoma recurred after his ini­tial Pfiz­er shot. The tumor­ous ulcer appeared in the armpit of the same arm in which the man had received the injec­tion, and then regressed spon­ta­neous­ly. A sec­ond shot of the vac­cine, deliv­ered three weeks lat­er, pro­duced no fur­ther lesions, Man­gold told me, and the whole ordeal could have sim­ply been a coin­ci­dence. He felt that he’d been “thread­ing the nee­dle” to go pub­lic with the case report giv­en that uncer­tain­ty.

    Ladan Zand, a nephrol­o­gist at the Mayo Clin­ic in Rochester, Min­neso­ta, faced the same conun­drum when she co-authored a paper last year detail­ing five patients who had a relapse of kid­ney dis­ease fol­low­ing mRNA COVID vac­ci­na­tion. Her team also doc­u­ment­ed eight patients who were new­ly diag­nosed with the dis­ease, known as glomeru­lonephri­tis, after receiv­ing the shot. But Zand cau­tions that those patients might have had under­ly­ing kid­ney dis­ease and not been aware of it. Peo­ple infect­ed with the nov­el coro­n­avirus also show high­er rates of kid­ney-func­tion decline over time. “I spend half of my vis­its now ask­ing patients to get vac­ci­nat­ed,” she said. “If you were to com­pare the risks and ben­e­fits, the ben­e­fits of the vac­cine way out­weigh the risk of rare enti­ties that, for the most part, seem to be self-lim­it­ing.”

    ...

    While Michel remains unsure about his fourth shot, he has con­tin­ued to be out­spo­ken on the ben­e­fits of vac­ci­na­tion over­all, and often speaks to Bel­gian media on the top­ic. At the same time, he has become a stronger advo­cate for broad­er track­ing of adverse events from vaccines—an endeav­or he and oth­ers in drug devel­op­ment call “phar­ma­covig­i­lance.” “We need to make sure that some phar­ma­covig­i­lance pro­grams are pow­ered to detect very, very rare side effects,” Michel told me. Eich­ler, who was involved in drug reg­u­la­tion for the Euro­pean Med­i­cines Agency, said that while some doc­tors may be “afi­ciona­dos” of ran­dom­ized con­trolled tri­als as the only valid source of med­ical evi­dence, oth­er types of infor­ma­tion are need­ed. Michel’s case shows why: You’ve got a patient “who is a pro­fes­sor of med­i­cine, who expe­ri­ences the side effects and says, ‘Okay, this must be a side effect,’” Eich­ler said. That “rings the bells. Could Michel have ever come up in an RCT? My answer is prob­a­bly not.”
    ...

    But then we get to the tru­ly inex­plic­a­ble aspects of this sto­ry: if the dan­ger asso­ci­at­ed with the COVID vac­cines are asso­ci­at­ed with the effect on T‑cells induced by specif­i­cal­ly mRNA vac­cines, what about all the non-mRNA COVID vac­cine options for patients like Gold­man? Can’t he just take the AstraZeneca vac­cine instead? Or the John­son & John­son vac­cine? How about the new­ly-approved Novavax vac­cine? There are plen­ty of non-mRNA options. And Gold­man him­self even empha­sized how the risks found with these oth­er vac­cines were vast­ly out­weighed by the risks of COVID:

    ...
    I hap­pened to speak with Michel by phone in April 2021, months before his can­cer diag­no­sis. I’d called him to dis­cuss anoth­er poten­tial side effect of COVID vac­ci­na­tion, one asso­ci­at­ed in par­tic­u­lar with the shot made by AstraZeneca. By that point, 220 peo­ple who’d received that vac­cine had devel­oped an unusual—and very dangerous—blood-clotting syn­drome, which was char­ac­ter­ized by an atyp­i­cal low platelet count. At least sev­en peo­ple in the U.K. alone had died of the com­pli­ca­tion. Michel patient­ly laid out the dif­fer­ent mech­a­nisms that might explain this strange con­di­tion. But he was quick to add that the mRNA COVID vac­cines were built in a way that could mit­i­gate the risk of this par­tic­u­lar prob­lem.

    ...

    When we talked about the poten­tial side effects of the AstraZeneca vac­cine last year, Michel made it clear that, in the big pic­ture, any chance of seri­ous com­pli­ca­tions from the shots would be orders of mag­ni­tude small­er than the chance of com­pli­ca­tions from the pan­dem­ic ill­ness itself. If COVID vac­cines caused clot­ting dis­or­ders or myocardi­tis in a tiny per­cent­age of those who received them, he assured me, COVID would lead to stroke or heart inflam­ma­tion in a much larg­er group.

    The risks and ben­e­fits for each vac­cine should be weighed against each oth­er, he con­tin­ued. If AstraZeneca were the only option, then its pro­tec­tion might be worth the very small risk of devel­op­ing a rare blood dis­or­der. But giv­en the avail­abil­i­ty of Pfiz­er, Mod­er­na, and oth­er COVID vac­cines, many peo­ple could opt for a safer alter­na­tive.
    ...

    And yet, despite Gold­man’s assur­ances about the safe­ty of the AstraZeneca vac­cine, we find that he’s appar­ent­ly still try­ing to decide whether or not to get anoth­er mRNA boost­er shot or no vac­cine at all. WTF!?!?! Why?! Why not just take one of the non-mRNA vac­cines? It’s tru­ly bizarre:

    ...
    The Gold­mans’ paper, for its part, notes that it would be “pre­ma­ture” to extrap­o­late the find­ings from Michel to oth­er patients with the same kind of can­cer, and that the link, even if it were proved, should not dis­cour­age gen­er­al uptake of “much-need­ed vac­cines.” An unusu­al para­graph tacked onto the bot­tom of the arti­cle under­scores the point. Marked “Patient Per­spec­tive,” and writ­ten in the third per­son, it notes that Michel him­self “remains con­vinced that mRNA vac­cines rep­re­sent very effi­cient prod­ucts with a favor­able ben­e­fit-risk ratio,” and that he hopes the report will encour­age fur­ther research.

    In mid-Feb­ru­ary, Michel spiked a sud­den fever. COVID had final­ly caught up with him.

    Giv­en that he was immuno­com­pro­mised by six rounds of can­cer chemother­a­py, Michel knew that his doc­tors would need to act quick­ly. He soon received an infu­sion of the mon­o­clon­al-anti­body drug sotro­vimab, and man­aged to recov­er with­out inci­dent; his lymph nodes stayed bless­ed­ly qui­et, and there was no resur­gence of his can­cer. Now he’s eli­gi­ble for a sec­ond boost­er shot, but he’s not sure whether he should take it. “I don’t know what I will do,” he said.

    Would anoth­er dose of the vac­cine cause anoth­er round of can­cer lesions? Michel and the sci­en­tists who have been in touch with him are still mulling the evi­dence about whether his orig­i­nal can­cer flare was sim­ply a fluke. Steven Hor­witz, a med­ical oncol­o­gist at Memo­r­i­al Sloan Ket­ter­ing who focus­es on the care of patients with lym­phoma, has looked more close­ly at vac­cine side effects since hear­ing about Michel’s case, and feels reas­sured by what he’s found. “Of our patients who received mRNA COVID vac­cines, we have not seen any clear­ly relat­ed and doc­u­ment­ed relaps­es or pro­gres­sions,” he told me via email. Mean­while, lym­phomas and the treat­ments giv­en for them can weak­en the immune sys­tem, putting affect­ed patients at high­er risk of severe COVID-19 if infect­ed. “Vac­ci­na­tion remains the most effec­tive way to mit­i­gate that risk,” he said.

    ...

    Around the time of his Feb­ru­ary fol­low-up, Michel received a mes­sage from a doc­tor who had read his self-ref­er­en­tial case report. The doctor’s moth­er had been diag­nosed with the same sub­type of lym­phoma that Michel has fol­low­ing a COVID boost­er shot. More recent­ly, he got an email from a woman whose sis­ter had been vac­ci­nat­ed and received that diag­no­sis the fol­low­ing month. Again, these could be coin­ci­dences. Or maybe they are the sec­ond and third data points in a grow­ing set. The pos­si­ble con­nec­tion between Michel’s lym­phoma flare and his COVID-19 vac­ci­na­tion occu­pies much of his think­ing these days. “If it exists, it must be very rare,” he said. But he doesn’t regret going pub­lic with his case. “I’m still con­vinced it was the right thing to do.”
    ...

    So best of luck to Michel Gold­man in his bat­tle with lym­phoma. A bat­tle that hope­ful­ly won’t involve any new bouts of COVID. And/or any new rare side-effects that get sys­tem­at­i­cal­ly ignored.

    Posted by Pterrafractyl | September 26, 2022, 4:01 pm
  2. Here’s an arti­cle from a few weeks ago fol­low­ing up on one of the more dis­turb­ing sto­ries to emerge from the COVID pan­dem­ic. The sto­ry also poten­tial­ly relates to Metabio­ta and the devel­op­ment of pan­dem­ic insur­ance prod­ucts:

    Recall how Palan­tir man­aged to get gov­ern­ment con­tracts to help mon­i­tor the COVID out­break. And not just with the CDC in the US. As of April of 2020, Palan­tir was work­ing with over a dozen gov­ern­ments in assist­ing their COVID response, includ­ing the UK’s Nation­al Health Ser­vice (NHS). Palan­tir’s NHS con­tract involved using Palan­tir’s Foundry plat­form to help the NHS deter­mine cur­rent occu­pan­cy lev­els at hos­pi­tals, down to the num­ber and type of beds, as well as the capac­i­ty of acci­dent and emer­gency, depart­ments and wait­ing times. Palan­tir was get­ting access to some pret­ty gran­u­lar UK med­ical data. The kind of data that could pre­sum­ably be very handy for any com­pa­ny involved with pre­dict­ing and track­ing emerg­ing pan­demics. And with the NHS putting up a new £360 mil­lion con­tract com­ing for ten­der for a major new data plat­form, it sounds like Palan­tir is very keen on get­ting that con­tract and tak­ing steps to make it hap­pen. Steps like hir­ing key NHS offi­cials.

    And now we’re learn­ing that Palan­tir has plans to expand its foot­print in the UK health sys­tem. Secret plans. Well, for­mer­ly secret plans. Plans to avoid pub­lic scruti­ny by buy­ing expand­ing in this mar­ket indi­rect­ly. Instead of Palan­tir direct­ly offer­ing ser­vices to UK health data firms, the com­pa­ny is going on a buy­ing spree instead, tar­get­ing small health data firms across the UK.

    Intrigu­ing­ly, it sounds like Palan­tir is offer­ing the founders of these firms extra sweet deals if the founders agree to shift their data and ser­vices to Palan­tir’s Foundry. In oth­er words, Palan­tir real­ly wants to get its hands on that data. This is par­tic­u­lar­ly inter­est­ing giv­en that, as we’re going to see, the exist­ing NHS con­tracts with Palan­tir are explic­it that “the data con­trol stays with the own­er of the data, not with Palan­tir.” So at the same time Palan­tir appears to be poised to place itself at the heart of the NHS’s health­care data, but not nec­es­sar­i­ly with ‘con­trol’ over that data, the com­pa­ny is simul­ta­ne­ous­ly going around buy up small UK health data firms in a push to get as much of that data into Palan­tir’s inter­nal Foundry plat­form as pos­si­ble.

    And this is all, of course, hap­pen­ing under the watch of a UK gov­ern­ment that appears to be ani­mat­ed by the ghost of Ayn Rand. That’s the broad­er con­text here: the cur­rent right-wing UK gov­ern­ment is keen on hand­ing as much of the pub­lic sec­tor over to the pri­vate sec­tor as pos­si­ble. Out­sourc­ing the NHS’s health data ser­vices to a fas­cist like Peter Thiel just makes sense. Fas­cist sense, but that’s the kind of sense guid­ing the UK these days, which is why we should prob­a­bly start ask­ing what oth­er kind of fas­cist goals might be achiev­able once you hand a nation’s health care data over to one of the world’s lead­ing fas­cists:

    Finan­cial Times

    Palan­tir gears up to expand its reach into UK’s NHS
    US data ana­lyt­ics group hires health ser­vice exec­u­tives in bid to secure £360mn con­tract

    Mad­hu­mi­ta Mur­gia and Sarah Neville in Lon­don
    June 8 2022

    US data ana­lyt­ics group Palan­tir is gear­ing up to become the under­ly­ing oper­at­ing sys­tem for the UK’s Nation­al Health Ser­vice, poach­ing senior NHS offi­cials as part of a bid to win a £360mn con­tract to man­age the data of mil­lions of patients across Eng­land.

    The com­pa­ny, best known for its ties to the secu­ri­ty, defence and intel­li­gence sec­tors, has been the NHS’s go-to data ana­lyt­ics provider dur­ing its Covid-19 cri­sis response. Its Foundry soft­ware was used in the man­age­ment of ven­ti­la­tors and PPE equip­ment, deliv­ery of the nation­wide vac­ci­na­tion pro­gramme and help­ing to tack­le the back­log of 6mn patients wait­ing for elec­tive care.

    The secre­tive com­pa­ny, co-found­ed by Peter Thiel, an ear­ly investor in Face­book and promi­nent sup­port­er of for­mer US pres­i­dent Don­ald Trump, is now manoeu­vring to expand its reach into the NHS over the next decade.

    That push has prompt­ed pri­va­cy activists and some with­in the NHS to voice con­cerns about Palantir’s suit­abil­i­ty to run nation­al health sys­tems as well as the dan­gers of the NHS rely­ing on a sin­gle pri­vate com­pa­ny for its key func­tions.

    Over the next few months, Palan­tir will bid for the five-year £360mn con­tract for the pro­posed Fed­er­at­ed Data Plat­form (FDP), a new data tool to con­nect and inte­grate patient and oth­er data sources from across the health sys­tem, so real-time deci­sions can be made effec­tive­ly by clin­i­cians and bureau­crats. The con­tract is due to be award­ed in Novem­ber this year.

    “This would be the veins through which patient data would flow, very much the oper­at­ing sys­tem for data in the NHS,” said Phil Booth, founder of health data advo­ca­cy group med­Con­fi­den­tial. “This is clear­ly a core ele­ment of the NHS’s entire dig­i­tal trans­for­ma­tion pro­gramme.”

    To help its chances, Palan­tir has hired two senior NHS offi­cials in recent months — Indra Joshi, the NHS’s for­mer head of arti­fi­cial intel­li­gence, and Har­jeet Dhali­w­al, for­mer deputy to Ming Tang, NHS England’s data chief, who is respon­si­ble for the FDP con­tract and for Palantir’s pre­vi­ous con­tracts with the NHS.

    A for­mer senior health offi­cial said that eye­brows with­in the ser­vice had been raised by “the revolv­ing door between gov­ern­ment, NHS and Palan­tir”.

    The UK is a key mar­ket for Palan­tir, which employs more than 600 peo­ple — its largest sin­gle office — and plans to hire an addi­tion­al 250 staff this year. The com­pa­ny already process­es sen­si­tive nation­al secu­ri­ty data for UK pub­lic author­i­ties, includ­ing the Min­istry of Defence and cab­i­net office.

    “Palan­tir has said this is a must-win deal for them,” said a per­son with knowl­edge of Palantir’s expan­sion plans in the UK. “This is a five-year con­tract, with an option for an exten­sion for two years. [Many peo­ple] think it’s real­ly £1bn over 10 years. Once Palan­tir is in, how are you going to remove them?

    The move comes as Palantir’s growth slows sig­nif­i­cant­ly. Its sales in the first quar­ter of this year rose 31 per cent, com­pared with a rise of 49 per cent in the same peri­od last year.

    Although the com­pa­ny has said it wants to piv­ot to doing more com­mer­cial work, gov­ern­ment con­tracts still have a big impact on its finan­cial health. Gov­ern­ment rev­enue was up 16 per cent year on year in the first quar­ter, com­pared with a 76 per cent increase the year before.

    Accord­ing to sev­er­al fig­ures at the NHS and at its sup­pli­ers, Palan­tir is viewed as the fron­trun­ner for the FDP con­tract, which runs until 2027. The plat­form will be used for the nation­al man­age­ment of vac­cines and immu­ni­sa­tion pro­grammes, pop­u­la­tion health, elec­tive wait­ing lists and med­i­cines and equip­ment sup­ply chains, among oth­er appli­ca­tions.

    In an infor­ma­tion pack pro­vid­ed to poten­tial sup­pli­ers by the NHS, and seen by the Finan­cial Times, Palantir’s tech­nol­o­gy was laud­ed as a mod­el. “The cur­rent plat­form (Foundry) is . . . deliv­er­ing huge ben­e­fits and was crit­i­cal to the suc­cess of the vac­ci­na­tion and PPE pro­grammes.”

    Rolling out this type of sys­tem across the rest of the health ser­vice “has the poten­tial to deliv­er £3.6bn ben­e­fits over 10 years”, the doc­u­ment said.

    One senior NHS offi­cial said Palan­tir was well-placed to win the bid, par­tic­u­lar­ly when its work was assessed against fail­ures else­where in the Covid response, notably defi­cien­cies in the pro­gramme to test and track con­tacts of infect­ed peo­ple.

    “If you were to com­pare the [suc­cess­ful] work that Palan­tir did in vac­cines and PPE, with the work that Palan­tir didn’t do, which was test and trace . . . [Palan­tir] hasn’t let us down,” he said.

    Oth­er poten­tial bid­ders could include con­sult­ing firms such as Accen­ture, PwC and KPMG, who have tech­nol­o­gy part­ners such as Ora­cle and Microsoft.

    ...

    NHS Eng­land said the pro­cure­ment process would start in ear­ly July and that it would be an open pro­cure­ment to allow all sup­pli­ers a chance to bid.

    “The NHS should not be com­mis­sion­ing a sin­gle sup­pli­er to be the provider of its oper­at­ing sys­tem for data for Eng­land. We need to be build­ing the capac­i­ty to do that our­selves,” said Booth of med­Con­fi­den­tial. “What­ev­er sup­pli­er is con­tract­ed should be com­plete­ly trans­par­ent, but Palan­tir is a black box.”

    Palantir’s involve­ment in the NHS has been par­tic­u­lar­ly con­tro­ver­sial among civ­il lib­er­ties groups. Last July, a group of pri­va­cy cam­paign­ers led by tech jus­tice group Fox­glove launched the “No Palan­tir in Our NHS” cam­paign owing to its work with the US immi­gra­tion ser­vice and close links to nation­al secu­ri­ty agen­cies.

    While a senior NHS offi­cial acknowl­edged the ques­tion of data secu­ri­ty was “com­plete­ly valid”, he said NHS Eng­land had “gone into this in a lot of depth” and believed that Palan­tir was “one of the few com­pa­nies that can actu­al­ly address those con­cerns legit­i­mate­ly”. Under the licence agree­ments that the NHS has pre­vi­ous­ly entered into with the com­pa­ny, “the data con­trol stays with the own­er of the data, not with Palan­tir”, he not­ed.

    Not all are con­vinced. “Many are already con­cerned about com­mer­cial inter­ests hav­ing involve­ment at all, let alone a com­pa­ny that helped Don­ald Trump with his ICE deten­tions at the Mex­i­can bor­der,” said Booth. “Is this a prop­er cor­po­rate enti­ty to be work­ing at the heart of the NHS?”

    ————

    “Palan­tir gears up to expand its reach into UK’s NHS” by Mad­hu­mi­ta Mur­gia and Sarah Neville; Finan­cial Times; 06/08/2022

    Over the next few months, Palan­tir will bid for the five-year £360mn con­tract for the pro­posed Fed­er­at­ed Data Plat­form (FDP), a new data tool to con­nect and inte­grate patient and oth­er data sources from across the health sys­tem, so real-time deci­sions can be made effec­tive­ly by clin­i­cians and bureau­crats. The con­tract is due to be award­ed in Novem­ber this year.”

    It’s a mas­sive prize: a five-year £360mn con­tract to build a new data plat­form that will con­nect a myr­i­ad of health data sources. And a con­tract that’s almost guar­an­teed to be extend­ed for at least anoth­er five years and prob­a­bly indef­i­nite­ly. And based on insid­er com­ments, it sounds like Palan­tir is the like­ly choice for this con­tract when the gov­ern­ment ulti­mate­ly makes that deci­sion next month. Yes, Palan­tir — a com­pa­ny found­ed by an open fas­cist and financed by the CIA — is poised to get embed­ded at the heart of the NHS oper­a­tions for the fore­see­able future:

    ...
    The com­pa­ny, best known for its ties to the secu­ri­ty, defence and intel­li­gence sec­tors, has been the NHS’s go-to data ana­lyt­ics provider dur­ing its Covid-19 cri­sis response. Its Foundry soft­ware was used in the man­age­ment of ven­ti­la­tors and PPE equip­ment, deliv­ery of the nation­wide vac­ci­na­tion pro­gramme and help­ing to tack­le the back­log of 6mn patients wait­ing for elec­tive care.

    ...

    That push has prompt­ed pri­va­cy activists and some with­in the NHS to voice con­cerns about Palantir’s suit­abil­i­ty to run nation­al health sys­tems as well as the dan­gers of the NHS rely­ing on a sin­gle pri­vate com­pa­ny for its key func­tions.

    ...

    “Palan­tir has said this is a must-win deal for them,” said a per­son with knowl­edge of Palantir’s expan­sion plans in the UK. “This is a five-year con­tract, with an option for an exten­sion for two years. [Many peo­ple] think it’s real­ly £1bn over 10 years. Once Palan­tir is in, how are you going to remove them?

    ...

    Accord­ing to sev­er­al fig­ures at the NHS and at its sup­pli­ers, Palan­tir is viewed as the fron­trun­ner for the FDP con­tract, which runs until 2027. The plat­form will be used for the nation­al man­age­ment of vac­cines and immu­ni­sa­tion pro­grammes, pop­u­la­tion health, elec­tive wait­ing lists and med­i­cines and equip­ment sup­ply chains, among oth­er appli­ca­tions.

    In an infor­ma­tion pack pro­vid­ed to poten­tial sup­pli­ers by the NHS, and seen by the Finan­cial Times, Palantir’s tech­nol­o­gy was laud­ed as a mod­el. “The cur­rent plat­form (Foundry) is . . . deliv­er­ing huge ben­e­fits and was crit­i­cal to the suc­cess of the vac­ci­na­tion and PPE pro­grammes.”

    Rolling out this type of sys­tem across the rest of the health ser­vice “has the poten­tial to deliv­er £3.6bn ben­e­fits over 10 years”, the doc­u­ment said.

    One senior NHS offi­cial said Palan­tir was well-placed to win the bid, par­tic­u­lar­ly when its work was assessed against fail­ures else­where in the Covid response, notably defi­cien­cies in the pro­gramme to test and track con­tacts of infect­ed peo­ple.

    “If you were to com­pare the [suc­cess­ful] work that Palan­tir did in vac­cines and PPE, with the work that Palan­tir didn’t do, which was test and trace . . . [Palan­tir] hasn’t let us down,” he said.
    ...

    But as good as its chances are, Palan­tir isn’t tak­ing any chances with the hir­ing of key NHS offi­cials in recent months. The mes­sage is clear: NHS offi­cials can expect cushy job offers from Palan­tir in exchange for this con­tract:

    ...
    To help its chances, Palan­tir has hired two senior NHS offi­cials in recent months — Indra Joshi, the NHS’s for­mer head of arti­fi­cial intel­li­gence, and Har­jeet Dhali­w­al, for­mer deputy to Ming Tang, NHS England’s data chief, who is respon­si­ble for the FDP con­tract and for Palantir’s pre­vi­ous con­tracts with the NHS.

    A for­mer senior health offi­cial said that eye­brows with­in the ser­vice had been raised by “the revolv­ing door between gov­ern­ment, NHS and Palan­tir”.
    ...

    Final­ly, note the key assur­ance we’re hear­ing about data pri­va­cy con­cerns: The data processed by Palan­tir’s sys­tems for the NHS Under the pre­vi­ous licens­ing agree­ments came with the stip­u­la­tion that “the data con­trol stays with the own­er of the data, not with Palan­tir.” So if they sta­tus quo is main­tain, Palan­tir could end up at the heart of the NHS’s health data pro­cess­ing while not actu­al­ly hav­ing con­trol of the data. It would be inter­est­ing to know what exact­ly that kind of arrange­ment entails in terms of real world data pri­va­cy impli­ca­tions. Because whether or not Palan­tir ‘con­trols’ the data, it pre­sum­ably needs to be able to access it if it’s going to be offer­ing these ser­vices:

    ...
    Palantir’s involve­ment in the NHS has been par­tic­u­lar­ly con­tro­ver­sial among civ­il lib­er­ties groups. Last July, a group of pri­va­cy cam­paign­ers led by tech jus­tice group Fox­glove launched the “No Palan­tir in Our NHS” cam­paign owing to its work with the US immi­gra­tion ser­vice and close links to nation­al secu­ri­ty agen­cies.

    While a senior NHS offi­cial acknowl­edged the ques­tion of data secu­ri­ty was “com­plete­ly valid”, he said NHS Eng­land had “gone into this in a lot of depth” and believed that Palan­tir was “one of the few com­pa­nies that can actu­al­ly address those con­cerns legit­i­mate­ly”. Under the licence agree­ments that the NHS has pre­vi­ous­ly entered into with the com­pa­ny, “the data con­trol stays with the own­er of the data, not with Palan­tir”, he not­ed.

    Not all are con­vinced. “Many are already con­cerned about com­mer­cial inter­ests hav­ing involve­ment at all, let alone a com­pa­ny that helped Don­ald Trump with his ICE deten­tions at the Mex­i­can bor­der,” said Booth. “Is this a prop­er cor­po­rate enti­ty to be work­ing at the heart of the NHS?”
    ...

    And that ‘data con­trol’ arrange­ment brings us to the lat­est update we got on Palan­tir’s plans for expand­ing its NHS foot­print. Secur­ing that £360mn con­tract is just the one part of this expan­sion. The more pub­lic part. There’s a qui­et part too: Palan­tir has been try­ing to qui­et­ly ‘hoover up’ all sorts of UK health data firms. The idea is that by buy­ing firms out­right, Palan­tir can avoid some of the polit­i­cal resis­tance it faces with things like NHS con­tracts.

    And then we get to this inter­est­ing detail: it also sounds like Palan­tir has been sweet­en­ing the buy­out deals for these small firms if the founders of the firms agree to move their data and ser­vices over to Palan­tir’s Foundry. That sure sounds like a recipe for gain­ing con­trol over that data. So what have to ask, what else is Palan­tir plan­ning on using this data for? Pan­dem­ic insur­ance-relat­ed data analy­sis is one pos­si­bil­i­ty that comes to mind but it’s just one exam­ple of the array of pos­si­ble appli­ca­tion for this kind of data. That’s part of what makes this sto­ry some­thing to watch: Palan­tir does­n’t just want those NHS con­tracts. The com­pa­ny wants that health data and it’s ‘hoover­ing up’ firms across the UK to get it:

    Bloomberg

    Peter Thiel’s Palan­tir Had Secret Plan to Crack UK’s NHS: ‘Buy­ing Our Way In’

    * US data-ana­lyt­ics com­pa­ny aimed to buy up small­er rivals
    * Sil­i­con Val­ley data firm bid­ding for £360 mil­lion NHS con­tract

    By Olivia Solon
    Sep­tem­ber 30, 2022 at 12:00 AM CDT

    Palan­tir Tech­nolo­gies had a secret plan to deep­en its rela­tion­ship with the UK’s Nation­al Health Ser­vice with­out pub­lic scruti­ny.

    The US data-ana­lyt­ics com­pa­ny aimed to buy up small­er rivals that already had an exist­ing rela­tion­ship with the NHS, accord­ing to emails and strat­e­gy doc­u­ments seen by Bloomberg. This approach would hope­ful­ly allow Palan­tir to avoid fur­ther scruti­ny in work­ing with one of the largest depos­i­to­ries of health data.

    Palantir’s region­al head Louis Mosley described the strat­e­gy in an email enti­tled “Buy­ing our way in…!” sent in Sept. 2021, which out­lined “hoover­ing up” small busi­ness­es serv­ing the NHS to “take a lot of ground and take down a lot of polit­i­cal resis­tance.”

    The NHS, one of the world’s largest employ­ers with a recent annu­al bud­get close to £190 bil­lion ($208 bil­lion), has become a key client for Palan­tir. It hired the US tech firm to help with its Covid-19 response, and cur­rent­ly has a £360 mil­lion con­tract com­ing up for ten­der — a deal Palan­tir is hop­ing to win.

    While Palan­tir has so far been unsuc­cess­ful in buy­ing up NHS sup­pli­ers, the doc­u­ments seen by Bloomberg show how Palan­tir hopes to deep­en its busi­ness with a key client, both by mak­ing key hires from the NHS and via poten­tial acqui­si­tions.

    Palan­tir has con­sis­tent­ly faced crit­i­cism in coun­tries includ­ing the US and UK from civ­il lib­er­ties groups, who have been con­cerned by its track record for pro­vid­ing tools to gov­ern­ment agen­cies that help enable broad sur­veil­lance of pop­u­la­tions, for exam­ple by US Cus­toms and Enforce­ment to find undoc­u­ment­ed migrants for depor­ta­tion. Law­mak­ers in the UK have also voiced con­cern over Palantir’s tech­nol­o­gy.

    ...

    ‘Start Scop­ing’

    Co-found­ed in 2003 by Face­book Inc. board mem­ber Peter Thiel, Palan­tir quick­ly won the atten­tion and finan­cial back­ing of In-Q-Tel, the ven­ture invest­ing arm of the U.S. Cen­tral Intel­li­gence Agency. The start­up count­ed the CIA among its first cus­tomers, and cul­ti­vat­ed an ear­ly rep­u­ta­tion for secre­cy.

    Named for the all-see­ing stones used in J.R.R. Tolkien’s fic­tion­al The Lord of the Rings tril­o­gy, Palan­tir now counts dozens of US gov­ern­ment agen­cies as cus­tomers, with a a sig­nif­i­cant num­ber in the nation­al secu­ri­ty and defense space. Palan­tir lead­er­ship has for­sworn doing busi­ness in Chi­na and oth­er regions not aligned with US inter­ests, ele­vat­ing the impor­tance of UK deals. How­ev­er, despite pre­dict­ing $1.9 bil­lion in rev­enue for 2022, the firm has strug­gled to turn a prof­it. It’s share price is down about 56% so far this year.

    Accord­ing to Mosley’s email to col­leagues, suit­able UK takeover tar­gets were those with cred­i­ble lead­er­ship, annu­al rev­enue of between £5 mil­lion and £50 mil­lion, and already sell­ing soft­ware ser­vices to the NHS. Founders would be offered a “v. gen­er­ous buy­out sched­ule (say 10x, espe­cial­ly if all stock),” he wrote.

    Palan­tir would offer com­pen­sa­tion to founders for their equi­ty stake if they shift­ed all of their ser­vices into Palantir’s main data han­dling plat­form, Foundry, which was designed to orga­nize data from dis­parate sources.

    “I doubt any­body else is like­ly to come along and offer them some­thing as gen­er­ous as we would (we might even be their only real exit option),” Mosley wrote.

    Ear­ly in the Covid-19 pan­dem­ic, Foundry was used by the NHS to track the take-up of vac­cines and, more recent­ly, to man­age the back­log of patients wait­ing for elec­tive surg­eries. Since 2020, Palan­tir secured more than £37 mil­lion in con­tracts with the NHS and the Depart­ment of Health and Social Care, accord­ing to pub­lic spend­ing track­er Advice­Cloud.

    One of the com­pa­nies Palan­tir sought to acquire, short­ly before Mosley emailed his plan, was Beau­ti­ful Infor­ma­tion, an NHS-pri­vate part­ner­ship that gen­er­ates real-time infor­ma­tion for hos­pi­tals to use for bal­anc­ing resources with patient demand. Palan­tir lost out to Cana­di­an health-tech firm Vital­Hub Corp, which announced it bought Beau­ti­ful Infor­ma­tion for £1.55 mil­lion in Jan­u­ary.

    “I’m keen to start scop­ing more acqui­si­tion tar­gets like [Beau­ti­ful Infor­ma­tion],” Mosley wrote, adding that he had “a kit­ty,” a British term for a pot of mon­ey.

    Late in 2021, Palan­tir was also in advanced talks to invest more than £21 mil­lion into British data-ana­lyt­ics firm Sen­syne, in a deal code­named “Project Gon­dor” — a ref­er­ence to a fic­tion­al king­dom depict­ed in The Lord of the Rings — in return for Sen­syne using Palantir’s Foundry, accord­ing to an inter­nal doc­u­ment seen by Bloomberg.

    “There is noth­ing unusu­al about a com­pa­ny explor­ing invest­ments or acqui­si­tions,” Palantir’s spokesman said. He said the com­pa­ny had been approached with “two such oppor­tu­ni­ties” in 2021. “We declined to pro­ceed with either and have not acquired any com­pa­nies that work with the NHS,” he said.

    ...

    Palan­tir was also part of a group of sev­er­al investors that con­tributed $230 mil­lion to sup­port Baby­lon Hold­ings Ltd. going pub­lic in 2021, as part of a longer-term part­ner­ship between the two com­pa­nies that saw Baby­lon migrate some of its data to Palantir’s Foundry plat­form, Bloomberg report­ed.

    Lob­by Efforts

    Deals and takeovers were only part of Palantir’s approach, how­ev­er, the mes­sages seen by Bloomberg show. At the same time as the Baby­lon part­ner­ship, Palan­tir urged indus­try lob­by group TechUK to encour­age gov­ern­ment agen­cies to buy com­mer­cial off-the-shelf prod­ucts, such as Foundry, instead of build­ing their own bespoke tools.

    ...

    Palan­tir hired Glob­al Coun­sel — the strate­gic advi­so­ry firm co-found­ed by Peter Man­del­son, a British Lord and for­mer lead­ing advis­er to ex-Prime Min­is­ter Tony Blair — to help lob­by UK gov­ern­ment. It also recent­ly hired Indra Joshi and Har­jeet Dhali­w­al, key fig­ures from the NHS.

    “Glob­al Counsel’s work for Palan­tir is a mat­ter of pub­lic record,” a spokesper­son said in an emailed state­ment. “The rel­e­vant dec­la­ra­tions to statu­to­ry reg­is­ters and the NHS in rela­tion to this work have been made.”

    Crit­ics have chal­lenged the NHS’s lack of trans­paren­cy over hasti­ly exe­cut­ed deals dur­ing the pan­dem­ic. Palan­tir was paid a nom­i­nal £1 fee in March 2020 to run a Covid-19 data store to help the NHS allo­cate resources more effi­cient­ly, but has used the work as a case study in pitch­es for oth­er NHS con­tracts, accord­ing to two senior NHS offi­cials who were not autho­rized to speak to the media.

    Ahead of that deal, Palan­tir spent months woo­ing NHS chiefs, the Bureau of Inves­tiga­tive Jour­nal­ism report­ed in Feb­ru­ary 2021. In Decem­ber 2020, Palan­tir was grant­ed a new con­tract to con­tin­ue the data-store work in a £23.5 mil­lion deal that was not sub­ject to a pub­lic ten­der process.

    Palan­tir declined to com­ment, but NHS Eng­land said in a state­ment at the time that it had “always act­ed in accor­dance with its legal respon­si­bil­i­ties.”

    Despite hir­ing Glob­al Coun­sel, Palan­tir received crit­i­cism from law­mak­ers over their deep­en­ing rela­tion­ship with the NHS.

    “Patient trust is vital to our NHS, so for­eign tech com­pa­nies such as Palan­tir, with their his­to­ry of sup­port­ing mass sur­veil­lance, assist­ing in drone strikes, immi­gra­tion raids and pre­dic­tive polic­ing, must not be placed at the heart of our NHS,” British law­mak­er David Davis, a mem­ber of the Con­ser­v­a­tive Par­ty and for­mer Sec­re­tary of State for Exit­ing the Euro­pean Union, said dur­ing a House of Com­mons debate in June 2021.

    Inde­pen­dent media com­pa­ny Open­Democ­ra­cy sued the UK gov­ern­ment with the sup­port of legal non­prof­it Fox­glove for award­ing busi­ness to Palan­tir with­out a pub­lic ten­der process. The gov­ern­ment agreed not to extend the con­tract beyond Covid with­out a pub­lic con­sul­ta­tion. The push-back con­tin­ued in Sept. 2021, when the Depart­ment of Health and Social Care end­ed anoth­er data deal with Palan­tir, Bloomberg report­ed.

    Cori Crid­er, found­ing direc­tor of Fox­glove, said there are “real con­cerns” about whether Palan­tir offers the NHS val­ue for mon­ey, “or whether there is just a ‘shiny dash­board’ think­ing infect­ing some offi­cials.”

    It’s not known when the NHS will make a deci­sion for its upcom­ing £360 mil­lion ten­der. Oth­er poten­tial bid­ders include major con­sult­ing firms as well as large US tech com­pa­nies.

    “Foundry as a piece of soft­ware is entire­ly com­pe­tent,” said Phil Booth, coor­di­na­tor of British data-pri­va­cy cam­paign orga­ni­za­tion med­Con­fi­den­tial, adding that he did not have con­cerns about unau­tho­rized peo­ple access­ing patient data as that would be “sui­ci­dal” for Foundry.

    How­ev­er, he said that Palantir’s his­to­ry as a “Peter Thiel-backed, CIA-ini­ti­at­ed com­pa­ny” could deter patients from shar­ing their data. “We should get rid of Palan­tir and build our own open-source soft­ware,” he said.

    ———–

    “Peter Thiel’s Palan­tir Had Secret Plan to Crack UK’s NHS: ‘Buy­ing Our Way In’” By Olivia Solon; Bloomberg; 09/30/2022

    “The US data-ana­lyt­ics com­pa­ny aimed to buy up small­er rivals that already had an exist­ing rela­tion­ship with the NHS, accord­ing to emails and strat­e­gy doc­u­ments seen by Bloomberg. This approach would hope­ful­ly allow Palan­tir to avoid fur­ther scruti­ny in work­ing with one of the largest depos­i­to­ries of health data.

    You can see why Palan­tir is keen on this strat­e­gy: instead of deal­ing with all the headaches and pub­lic rela­tions chal­lenges of hav­ing Palan­tir direct­ly get new con­tracts with the UK’s NHS, just have Palan­tir buy up com­pa­nies that are already work­ing with NHS data. As long as Palan­tir can man­age to “hoover up” enough small com­pa­nies it’s only a mat­ter of time before its foothold is secured:

    ...
    Palantir’s region­al head Louis Mosley described the strat­e­gy in an email enti­tled “Buy­ing our way in…!” sent in Sept. 2021, which out­lined “hoover­ing up” small busi­ness­es serv­ing the NHS to “take a lot of ground and take down a lot of polit­i­cal resis­tance.”

    ...

    While Palan­tir has so far been unsuc­cess­ful in buy­ing up NHS sup­pli­ers, the doc­u­ments seen by Bloomberg show how Palan­tir hopes to deep­en its busi­ness with a key client, both by mak­ing key hires from the NHS and via poten­tial acqui­si­tions.

    ...

    Ear­ly in the Covid-19 pan­dem­ic, Foundry was used by the NHS to track the take-up of vac­cines and, more recent­ly, to man­age the back­log of patients wait­ing for elec­tive surg­eries. Since 2020, Palan­tir secured more than £37 mil­lion in con­tracts with the NHS and the Depart­ment of Health and Social Care, accord­ing to pub­lic spend­ing track­er Advice­Cloud.
    ...

    But buy­ing the UK health data firms was just the first step. The sec­ond step is to con­vince the new­ly-pur­chased firms to move all of their ser­vices to Palan­tir’s Foundry plat­form. It’s a reminder that Big Data giants have a lot of ways of get­ting their hands on pre­cious data. It’s also the kind of episode that rais­es the ques­tion of how many oth­er health data firms from around the world may have already made this qui­et­ly deci­sion to move their data and ser­vices to Palan­tir’s Foundry. Mov­ing this data into Palan­tir qui­et­ly and with­out the pub­lic notic­ing is at the core of the plan, after all:

    ...
    Accord­ing to Mosley’s email to col­leagues, suit­able UK takeover tar­gets were those with cred­i­ble lead­er­ship, annu­al rev­enue of between £5 mil­lion and £50 mil­lion, and already sell­ing soft­ware ser­vices to the NHS. Founders would be offered a “v. gen­er­ous buy­out sched­ule (say 10x, espe­cial­ly if all stock),” he wrote.

    Palan­tir would offer com­pen­sa­tion to founders for their equi­ty stake if they shift­ed all of their ser­vices into Palantir’s main data han­dling plat­form, Foundry, which was designed to orga­nize data from dis­parate sources.

    “I doubt any­body else is like­ly to come along and offer them some­thing as gen­er­ous as we would (we might even be their only real exit option),” Mosley wrote.

    ...

    Late in 2021, Palan­tir was also in advanced talks to invest more than £21 mil­lion into British data-ana­lyt­ics firm Sen­syne, in a deal code­named “Project Gon­dor” — a ref­er­ence to a fic­tion­al king­dom depict­ed in The Lord of the Ringsin return for Sen­syne using Palantir’s Foundry, accord­ing to an inter­nal doc­u­ment seen by Bloomberg.

    “There is noth­ing unusu­al about a com­pa­ny explor­ing invest­ments or acqui­si­tions,” Palantir’s spokesman said. He said the com­pa­ny had been approached with “two such oppor­tu­ni­ties” in 2021. “We declined to pro­ceed with either and have not acquired any com­pa­nies that work with the NHS,” he said.

    ...

    Palan­tir was also part of a group of sev­er­al investors that con­tributed $230 mil­lion to sup­port Baby­lon Hold­ings Ltd. going pub­lic in 2021, as part of a longer-term part­ner­ship between the two com­pa­nies that saw Baby­lon migrate some of its data to Palantir’s Foundry plat­form, Bloomberg report­ed.
    ...

    And then there’s the oth­er angle to Palan­tir’s strat­e­gy: lob­by­ing gov­ern­ment offi­cials and/or hir­ing them for lucra­tive jobs. It’s a strat­e­gy that has clear­ly already worked, as the £23.5 mil­lion deal Decem­ber 2020, con­tract to con­tin­ue the Palan­tir’s COVID-relat­ed work that was not sub­ject to a pub­lic ten­der process. Lob­by­ing works:

    ...
    Deals and takeovers were only part of Palantir’s approach, how­ev­er, the mes­sages seen by Bloomberg show. At the same time as the Baby­lon part­ner­ship, Palan­tir urged indus­try lob­by group TechUK to encour­age gov­ern­ment agen­cies to buy com­mer­cial off-the-shelf prod­ucts, such as Foundry, instead of build­ing their own bespoke tools.

    ...

    Palan­tir hired Glob­al Coun­sel — the strate­gic advi­so­ry firm co-found­ed by Peter Man­del­son, a British Lord and for­mer lead­ing advis­er to ex-Prime Min­is­ter Tony Blair — to help lob­by UK gov­ern­ment. It also recent­ly hired Indra Joshi and Har­jeet Dhali­w­al, key fig­ures from the NHS.

    “Glob­al Counsel’s work for Palan­tir is a mat­ter of pub­lic record,” a spokesper­son said in an emailed state­ment. “The rel­e­vant dec­la­ra­tions to statu­to­ry reg­is­ters and the NHS in rela­tion to this work have been made.”

    Crit­ics have chal­lenged the NHS’s lack of trans­paren­cy over hasti­ly exe­cut­ed deals dur­ing the pan­dem­ic. Palan­tir was paid a nom­i­nal £1 fee in March 2020 to run a Covid-19 data store to help the NHS allo­cate resources more effi­cient­ly, but has used the work as a case study in pitch­es for oth­er NHS con­tracts, accord­ing to two senior NHS offi­cials who were not autho­rized to speak to the media.

    Ahead of that deal, Palan­tir spent months woo­ing NHS chiefs, the Bureau of Inves­tiga­tive Jour­nal­ism report­ed in Feb­ru­ary 2021. In Decem­ber 2020, Palan­tir was grant­ed a new con­tract to con­tin­ue the data-store work in a £23.5 mil­lion deal that was not sub­ject to a pub­lic ten­der process.

    ...

    Inde­pen­dent media com­pa­ny Open­Democ­ra­cy sued the UK gov­ern­ment with the sup­port of legal non­prof­it Fox­glove for award­ing busi­ness to Palan­tir with­out a pub­lic ten­der process. The gov­ern­ment agreed not to extend the con­tract beyond Covid with­out a pub­lic con­sul­ta­tion. The push-back con­tin­ued in Sept. 2021, when the Depart­ment of Health and Social Care end­ed anoth­er data deal with Palan­tir, Bloomberg report­ed.

    Cori Crid­er, found­ing direc­tor of Fox­glove, said there are “real con­cerns” about whether Palan­tir offers the NHS val­ue for mon­ey, “or whether there is just a ‘shiny dash­board’ think­ing infect­ing some offi­cials.”
    ...

    Final­ly, note the rather laugh­able assur­ances we’re get­ting, of all places, the coor­di­na­tor of British data-pri­va­cy cam­paign orga­ni­za­tion med­Con­fi­den­tial: we should­n’t be con­cerned about unau­tho­rized peo­ple access­ing patient data as that would be “sui­ci­dal” for Foundry. Yes, because we should all be super assured that Foundry — a plat­form built by a com­pa­ny long financed by the CIA’s In-Q-Tel — would­n’t spy on any data inap­pro­pri­ate­ly. That’s the appar­ent atti­tude held by the peo­ple tasked with cham­pi­oning patient data:

    ...
    It’s not known when the NHS will make a deci­sion for its upcom­ing £360 mil­lion ten­der. Oth­er poten­tial bid­ders include major con­sult­ing firms as well as large US tech com­pa­nies.

    “Foundry as a piece of soft­ware is entire­ly com­pe­tent,” said Phil Booth, coor­di­na­tor of British data-pri­va­cy cam­paign orga­ni­za­tion med­Con­fi­den­tial, adding that he did not have con­cerns about unau­tho­rized peo­ple access­ing patient data as that would be “sui­ci­dal” for Foundry.

    How­ev­er, he said that Palantir’s his­to­ry as a “Peter Thiel-backed, CIA-ini­ti­at­ed com­pa­ny” could deter patients from shar­ing their data. “We should get rid of Palan­tir and build our own open-source soft­ware,” he said.
    ...

    This is prob­a­bly a good time to recall that one of fas­cis­m’s best friends is a col­lec­tive sense of “we could­n’t imag­ine they would do things like that.” And also a good time to start imag­in­ing what a fas­cist might want to do with all of that data.

    Posted by Pterrafractyl | October 18, 2022, 3:48 pm
  3. The biotech indus­try has expe­ri­enced noth­ing less than a rev­o­lu­tion in recent years. Includ­ing an appar­ent rev­o­lu­tion in the speed at which new vac­cines and ther­a­peu­tics can be brought to mar­ket as evi­denced by the recent deci­sion to release the new mRNA Omi­cron-tar­get­ing boost­er vac­cines based entire­ly on mouse tri­al data. As we’ve seen from all the sto­ry about the ‘gain-of-func­tion’ exper­i­ments on coro­n­avirus and test­ing their lethal­i­ty on mice, a mouse’s immune sys­tem can behave very dif­fer­ent­ly from humans. But that’s the deci­sion that reg­u­la­tors made.

    And as we’re going to see in the fol­low­ing Unlim­it­ed Hang­out piece by Whit­ney Webb from back in August, it appears that the reg­u­la­to­ry envi­ron­ment for biotech in the US is poised to get even ‘loosers’. At least that’s one of the main ambi­tions of Nation­al Resilience, a new com­pa­ny that only came into exis­tence in Novem­ber of 2020. As we’re going to see, this is a com­pa­ny with ‘juice’. Not only did the com­pa­ny score a major invest­ment by the gov­ern­ment of Cana­da last July in its Ontario facil­i­ties, but it turns out the genet­ic mate­r­i­al for Mod­er­na’s Omi­cron mRNA boost­ers is pro­duced by Nation­al Resilience.

    So what made Mod­er­na decide to out­source its mRNA sup­pli­er to a com­pa­ny that did­n’t exist even two years ago? Well, that’s where the com­pa­ny’s deep con­nec­tions to both the gov­ern­ment and indus­try come into focus. Because Nation­al Resilience is stacked with a ‘Who’s Who’ list of insid­ers. The com­pa­ny was co-found­ed by Biotech ven­ture cap­i­tal­ist Robert Nelsen. But as we’re going to see, Nel­son actu­al­ly attrib­ut­es the idea for Nation­al Resilience to a Luciana Borio, then the vice-pres­i­dent of In-Q-Tel. The CEO of In-Q-Tel, Chris Dar­by, also sites on the board of direc­tors, along with Palan­tir’s Joe Lons­dale. Recall the role Lons­dale played in get­ting Sau­di mon­ey invest­ed in Sil­i­con Val­ley. Anoth­er fig­ure on Nation­al Resilience’s board with expe­ri­ence in the pri­va­tized intel­li­gence sec­tor is Drew Oet­ting of Cer­berus, the own­er of Dyn­Corp. Oth­er notable indus­try fig­ures involved with the com­pa­ny include for­mer FDA Com­mis­sion­er and Pfiz­er board mem­ber, Scott Got­tlieb and the for­mer CEO of the Bill & Melin­da Gates Foun­da­tion, Susan Desmond-Hell­mann.

    Also keep in mind the exten­sive role the US gov­ern­ment has already played in the devel­op­ment of Mod­er­na’s mRNA vac­cines. That long-stand­ing gov­ern­ment part­ner­ship came to light after Mod­er­na sued Pfiz­er claim­ing patent infringe­ment on a broad-spec­trum beta­coro­n­avirus vac­cine, with Mod­er­na assert­ing that it was con­duct­ing human mRNA vac­cine tri­als with US researchers as far back as 2015. Also recall how Mod­er­na ‘returned the favor’ for this gov­ern­ment sup­port by fil­ing patents that left out prop­er acknowl­edg­ment for the gov­ern­ment sci­en­tists work result­ing in gov­ern­ment law­suits. So we have Mod­er­na — a com­pa­ny that owes its exis­tence to major invest­ments from the US gov­ern­ment — decid­ing to out­source the genet­ic mate­ri­als for the new Omi­cron boost­ers to a brand new com­pa­ny stacked with peo­ple from the intel­li­gence world.

    But mak­ing the genet­ic mate­ri­als for mRNA ther­a­pies is far from Nation­al Resilience’s only ambi­tions. The com­pa­ny plans on becom­ing a key sup­pli­er of a vari­ety of bio­log­ics for the entire indus­try rang­ing from gene ther­a­pies, viral vec­tors, exper­i­men­tal vac­cines to oth­er “med­i­cines of tomor­row.”. In oth­er words, this com­pa­ny is plan­ning on spe­cial­iz­ing in exact­ly the kind of syn­thet­ic biol­o­gy tech­niques that are at the heart of mod­ern ‘dual use’ bio­log­i­cal war­fare research like what the Eco­HealthAl­liance was engaged in with ‘gain-of-func­tion’ coro­n­avirus­es. But Nation­al Resilience does­n’t appear to be plan­ning on car­ry­ing out this research on its own behalf. Instead, it wants to become the “AWS of biotech”, which sure sounds like a kind ‘gain-of-func­tion for-hire’ ser­vice.

    And then we get to per­haps the most dis­turb­ing ser­vice the com­pa­ny is plan­ning on offer­ing clients: “reg­u­la­to­ry sup­port”. That’s the term the com­pa­ny is using to describe ser­vices that sound like gov­ern­ment lob­by­ing designed to push prod­ucts through the reg­u­la­to­ry hur­dles faster. Again, don’t for­get that the lat­est Omi­cron boost­er were approved based on mouse tri­als alone. And it sounds like Nation­al Resilience is plan­ning on ensur­ing more deci­sions like that will hap­pen in the future:

    Unlim­it­ed Hang­out

    RNA for Moderna’s Omi­cron Boost­er Man­u­fac­tured by CIA-Linked Com­pa­ny
    Since late last year, mes­sen­ger RNA for Moderna’s COVID-19 vac­cines, includ­ing its recent­ly refor­mu­lat­ed Omi­cron boost­er, has been exclu­sive­ly man­u­fac­tured by a lit­tle known com­pa­ny with sig­nif­i­cant ties to US intel­li­gence.

    by Whit­ney Webb
    August 17, 2022

    Ear­li­er this week, the Unit­ed King­dom became the first coun­try to approve Moderna’s refor­mu­lat­ed ver­sion of its COVID-19 vac­cine, which claims to pro­vide pro­tec­tion against both the orig­i­nal form of the virus and the sig­nif­i­cant­ly less lethal but more trans­mis­si­ble Omi­cron vari­ant. The prod­uct was approved by the UK’s Med­i­cines and Health­care Prod­ucts Reg­u­la­to­ry Agency (MHRA) with the sup­port of the UK government’s Com­mis­sion on Human Med­i­cines.

    Described by UK offi­cials as a “sharp­ened tool” in the nation’s con­tin­ued vac­ci­na­tion cam­paign, the refor­mu­lat­ed vac­cine com­bines the pre­vi­ous­ly approved COVID-19 vac­cine with a “vac­cine can­di­date” tar­get­ing the Omi­cron vari­ant BA.1. That vac­cine can­di­date has nev­er been pre­vi­ous­ly approved and has not been the sub­ject of inde­pen­dent study. The MHRA approved the vac­cine based on a sin­gle, incom­plete human tri­al cur­rent­ly being con­duct­ed by Mod­er­na. The com­pa­ny pro­mot­ed incom­plete data from that tri­al in com­pa­ny press releas­es in June and July. The study has yet to be pub­lished in a med­ical jour­nal or peer reviewed. No con­cerns have been raised by any reg­u­la­to­ry agency, includ­ing the MHRA, regard­ing Moderna’s past his­to­ry of engag­ing in sus­pect and like­ly ille­gal activ­i­ty in past prod­uct tri­als, includ­ing for its orig­i­nal COVID-19 vac­cine.

    ...

    How­ev­er, unlike the company’s orig­i­nal COVID-19 vac­cine, the genet­ic mate­r­i­al, or mes­sen­ger RNA (mRNA), for this new vac­cine, includ­ing the new­ly for­mu­lat­ed genet­ic mate­r­i­al meant to pro­vide pro­tec­tion against the Omi­cron vari­ant, is being man­u­fac­tured, not by Mod­er­na, but by a rel­a­tive­ly new com­pa­ny that has received hard­ly any media atten­tion, despite its overt links to US intel­li­gence. Last Sep­tem­ber, it was qui­et­ly announced that a com­pa­ny called Nation­al Resilience (often referred to sim­ply as Resilience) would begin man­u­fac­tur­ing the mRNA for Mod­er­na COVID-19 vac­cine prod­ucts. Under the terms of the mul­ti-year agree­ment, “Resilience will pro­duce mRNA for the Mod­er­na COVID-19 vac­cine at its facil­i­ty in Mis­sis­sauga, Ontario, for dis­tri­b­u­tion world­wide.”

    “Rein­vent­ing Bio­man­u­fac­tur­ing”

    Nation­al Resilience was found­ed rel­a­tive­ly recent­ly, in Novem­ber 2020, and describes itself as “a man­u­fac­tur­ing and tech­nol­o­gy com­pa­ny ded­i­cat­ed to broad­en­ing access to com­plex med­i­cines and pro­tect­ing bio­phar­ma­ceu­ti­cal sup­ply chains against dis­rup­tion.” It has since been build­ing “a sus­tain­able net­work of high-tech, end-to-end man­u­fac­tur­ing solu­tions with the aim to ensure the med­i­cines of today and tomor­row can be made quick­ly, safe­ly, and at scale.” It fur­therplans to “rein­vent bio­man­u­fac­tur­ing” and “democ­ra­tize access to med­i­cines,” name­ly gene ther­a­pies, exper­i­men­tal vac­cines and oth­er “med­i­cines of tomor­row.”

    In pur­suit of those goals, the com­pa­ny announced it would “active­ly invest in devel­op­ing pow­er­ful new tech­nolo­gies to man­u­fac­ture com­plex med­i­cines that are defin­ing the future of ther­a­peu­tics, includ­ing cell and gene ther­a­pies, viral vec­tors, vac­cines, and pro­teins.” It was found­ed with the report­ed inten­tion “to build a bet­ter sys­tem for man­u­fac­tur­ing com­plex med­i­cines to fight dead­ly dis­eases” as a way to improve post-COVID “pan­dem­ic pre­pared­ness.”

    The com­pa­ny ini­tial­ly mar­ket­ed its man­u­fac­tur­ing capa­bil­i­ties as “the Resilience plat­form”, and offers prin­ci­pal­ly “RNA Modal­i­ties”, includ­ing RNA devel­op­ment for vac­cines, gene edit­ing and ther­a­peu­tics; and “Virus Pro­duc­tion”, includ­ing viral vec­tors, oncolyt­ic virus­es (i.e. a virus engi­neered to pref­er­en­tial­ly attack can­cer cells), virus­es for use in vac­cine devel­op­ment and gene-edit­ed virus­es for unspec­i­fied pur­pos­es. It is worth not­ing that, to date, many con­tro­ver­sial “gain-of-func­tion” exper­i­ments have jus­ti­fied mod­i­fy­ing virus­es for the same pur­pos­es as described by Nation­al Resilience’s Virus Pro­duc­tion capa­bil­i­ties. In addi­tion, Nation­al Resilience offers prod­uct for­mu­la­tions and oth­er modal­i­ties, such as bio­log­ics and cell ther­a­pies, to its clien­tele and the “Virus Pro­duc­tion” of its web­site has since been removed.

    Nation­al Resilience, being such a young com­pa­ny, has very few clients and there is lit­tle pub­licly avail­able infor­ma­tion on its man­u­fac­tur­ing capa­bil­i­ties aside from the company’s web­site. The firm only acquired its first com­mer­cial man­u­fac­tur­ing plant in March 2021, locat­ed in Boston, MA and pur­chased from Sanofi, fol­lowed short­ly there­after by the acqui­si­tion of anoth­er sep­a­rate plant locat­ed in Mis­sis­sauga, Ontario, Cana­da. Makeovers were announced for the plants, but lit­tle is pub­licly known about their progress. Pri­or to the acqui­si­tions, the com­pa­ny had been sub­leas­ing a Bay area facil­i­ty in Fre­mont, Cal­i­for­nia. Reporters were puz­zled at the time as to why a com­pa­ny with rough­ly 700 employ­ees at the time had acquired a total of 599,00 square feet of man­u­fac­tur­ing space after hav­ing only emerged from stealth less than 6 months pri­or.

    In April 2021, Nation­al Resilience acquired Olo­gy Bioser­vices Inc., which had received a $37 mil­lion con­tract from the US mil­i­tary the pre­vi­ous Novem­ber to devel­op an advanced anti-COVID-19 mon­o­clon­al anti­body treat­ment. This acqui­si­tion also pro­vid­ed Nation­al Resilience with its first Biosafe­ty Lev­el 3 (BSL‑3) lab­o­ra­to­ry and the abil­i­ty to man­u­fac­ture cell and gene ther­a­pies, live viral vac­cines and vec­tors and oncolyt­ic virus­es.

    Despite being in the ear­li­est stages of devel­op­ing its “rev­o­lu­tion­ary” man­u­fac­tur­ing capa­bil­i­ties, Nation­al Resilience entered into a part­ner­ship with the Gov­ern­ment of Cana­da in July of last year. Per that agree­ment, the Cana­di­an gov­ern­ment plans to invest CAD 199.2 mil­lion (about $154.9 mil­lion) into Nation­al Resilience’s Ontario-based sub­sidiary, Resilience Biotech­nolo­gies Inc. Most of those funds are des­tined for use in expand­ing the Ontario facil­i­ty that Resilience acquired last March and which is now man­u­fac­tur­ing the mRNA for Moderna’s COVID-19 prod­ucts. Canada’s Min­is­ter of Inno­va­tion, Sci­ence and Indus­try, François-Philippe Cham­pagne, assert­ed at the time that the invest­ment would “build future pan­dem­ic pre­pared­ness” and help “to grow Canada’s life sci­ence ecosys­tem as an engine for our eco­nom­ic recov­ery.” More recent­ly, in 2022, the com­pa­ny has announced a few new clients – Take­da, Opus Genet­ics and the US Depart­ment of Defense.

    Accord­ing to Nation­al Resilience’s exec­u­tives, the company’s ambi­tions appar­ent­ly go far beyond man­u­fac­tur­ing RNA and virus­es. For instance, Resilience CEO Rahul Singhvi has claimed that the com­pa­ny is seek­ing to build “the world’s most advanced bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing ecosys­tem.” Yet, Singhvi has declined to offer much in the way of specifics when it comes to exact­ly how the com­pa­ny plans to become the planet’s most elite bio­man­u­fac­tur­ing com­pa­ny.

    In an inter­view with The San Fran­cis­co Busi­ness Times, Singhvi states that Resilience is look­ing to fill its mas­sive man­u­fac­tur­ing plants with “tech­nolo­gies and peo­ple that can set and apply new stan­dards for man­u­fac­tur­ing cell ther­a­pies and gene ther­a­pies as well as RNA-based treat­ments.” Pri­or to Resilience, Singhvi was CEO of NovaVax and an oper­at­ing part­ner at Flag­ship Pio­neer­ing, which played a major role in the cre­ation and rise of Mod­er­na.

    Singhvi has fur­ther insist­ed that Nation­al Resilience is “not a ther­a­peu­tics com­pa­ny, not a con­trac­tor and not a tools com­pa­ny” and instead aims “to boost pro­duc­tion using the new ther­a­peu­tic modal­i­ties” such as RNA-based treat­ments, which have become nor­mal­ized in the COVID-19 era. Where­as con­tract man­u­fac­tur­ers “are like kitchens, with pots and pans ready for any recipe,” “what we’re try­ing to do is fix the recipes,” Singhvi has explained. One mem­ber of Resilience’s board of direc­tors, for­mer FDA Com­mis­sion­er and Pfiz­er Board mem­ber Scott Got­tlieb, has described the com­pa­ny as seek­ing to act as the equiv­a­lent of Ama­zon Web Ser­vices for the biotech­nol­o­gy indus­try.

    Essen­tial­ly, Resilience bills itself as offer­ing solu­tions that will allow “futur­is­tic” med­i­cines, includ­ing mRNA vac­cines, to be pro­duced more quick­ly and more effi­cient­ly, with the appar­ent goal of monop­o­liz­ing cer­tain parts of the bio­man­u­fac­tur­ing process. It also appears poised to become the man­u­fac­tur­er of choice for mRNA vac­cines and exper­i­men­tal ther­a­peu­tics in the event of a future pan­dem­ic, which some pub­lic health “phil­an­thropists” like Bill Gates have said is immi­nent.

    Per­haps the company’s most note­wor­thy ambi­tion relates to their claims that they sup­port clients through the gov­ern­ment reg­u­la­to­ry process. Giv­en the company’s empha­sis on speedy mass pro­duc­tion of exper­i­men­tal gene ther­a­pies, its stat­ed inten­tion of get­ting the “futur­is­tic” med­ical prod­ucts it man­u­fac­tures to mar­ket as quick­ly as pos­si­ble seems at odds with the slow­er, tra­di­tion­al reg­u­la­to­ry process­es. Indeed, one could eas­i­ly argue that the approvals of mRNA vac­cines for the first time in human his­to­ry dur­ing the COVID-19 cri­sis were only pos­si­ble because of the major relax­ing of reg­u­la­to­ry pro­ce­durse and safe­ty test­ing due to the per­ceived urgency of the sit­u­a­tion.

    Resilience seems intent on see­ing that phe­nom­e­non repeat itself. As pre­vi­ous­ly men­tioned, the com­pa­ny claims to allow for the set­ting and appli­ca­tion of “new stan­dards for man­u­fac­tur­ing cell ther­a­pies and gene ther­a­pies” and also says it plans to become a “tech­nol­o­gy-aggre­gat­ing stan­dards bear­er that helps ther­a­pies come to mar­ket more effi­cient­ly.” It pre­vi­ous­ly offered on its web­site “reg­u­la­to­ry sup­port” and “strat­e­gy con­sult­ing” to clients, sug­gest­ing that it would seek to medi­ate between clients and gov­ern­ment reg­u­la­tors in order to ful­fill its goal of hav­ing the prod­ucts it man­u­fac­tures tak­en to mar­ket more quick­ly. In addi­tion, upon launch, the com­pa­ny claimed it planned to obtain unspec­i­fied “reg­u­la­to­ry capa­bil­i­ties.” If so, it is cer­tain­ly notable that for­mer top Food and Drug Admin­is­tra­tion (FDA) offi­cials are either on the company’s board or, as will be not­ed short­ly, played a major role in the company’s cre­ation.

    The Peo­ple Behind Resilience

    Resilience was co-found­ed by Biotech ven­ture cap­i­tal­ist Robert Nelsen, who is known for lis­ten­ing “to science’s ear­li­est whis­pers, even when data are too ear­ly for just about any­one else.” Nelsen was one of the ear­li­est investors in Illu­mi­na, a Cal­i­for­nia-based gene-sequenc­ing hard­ware and soft­ware giant that is believed to cur­rent­ly dom­i­nate the field of genomics. As men­tioned in a pre­vi­ous Unlim­it­ed Hang­out inves­ti­ga­tion, Illu­mi­na is close­ly tied to the DARPA-equiv­a­lent of the Well­come Trust known as Well­come Leap, which is also focused on “futur­is­tic” and tran­shu­man­ist “med­i­cines.” Nelsen is now chair­man of Nation­al Resilience’s board, which is a “Who’s Who” of big play­ers from the US Nation­al Secu­ri­ty State, Big Phar­ma and Phar­ma-relat­ed “phil­an­thropy.”

    How­ev­er, while Nelsen has been giv­en much of the cred­it for cre­at­ing Resilience, he revealed in one inter­view that the idea for the com­pa­ny had actu­al­ly come from some­one else – Luciana Borio. In July of last year, Nelsen revealed that it was while talk­ing to Borio about “her work run­ning pan­dem­ic pre­pared­ness on the NSC [Nation­al Secu­ri­ty Coun­cil]” that had “helped lead to the launch of Nelsen’s $800 mil­lion bio­log­ics man­u­fac­tur­ing start­up Resilience.”

    At the time of their con­ver­sa­tion, Borio was the vice pres­i­dent of In-Q-tel, the ven­ture cap­i­tal arm of the CIA that has been used since its cre­ation in the ear­ly 2000s to found a num­ber of com­pa­nies, many of which act as Agency fronts. Pri­or to In-Q-Tel, she served as direc­tor for med­ical and biode­fense pre­pared­ness at the Nation­al Secu­ri­ty Coun­cil dur­ing the Trump admin­is­tra­tion and had pre­vi­ous­ly been the act­ing chief sci­en­tist at the FDA from 2015 to 2017.

    Borio is cur­rent­ly a senior fel­low for glob­al health at the Coun­cil on For­eign Rela­tions, a con­sul­tant to Gold­man Sachs, a mem­ber of the Bill Gates-fund­ed vac­cine alliance CEPI, and a part­ner at Nelsen’s ven­ture cap­i­tal firm ARCH Ven­ture Part­ners, which funds Resilience. Nelsen’s ARCH pre­vi­ous­ly fund­ed Nanosys, the com­pa­ny of the con­tro­ver­sial sci­en­tist Charles Lieber. Around the time of her con­ver­sa­tion with Nelsen that led to Resilience’s cre­ation, Borio was co-writ­ing a pol­i­cy paper for the Johns Hop­kins Cen­ter for Health Secu­ri­ty that rec­om­mend­ed link­ing COVID-19 vac­ci­na­tion sta­tus with food stamp pro­grams and rent assis­tance as a pos­si­ble means of coerc­ing cer­tain pop­u­la­tions to take the exper­i­men­tal vac­cine.

    Borio is hard­ly Resilience’s only In-Q-Tel con­nec­tion, as the CEO of In-Q-Tel, Chris Dar­by, sits on the company’s board of direc­tors. Dar­by is also on the board of direc­tors of the CIA Offi­cers Memo­r­i­al Foun­da­tion. Dar­by was also recent­ly a mem­ber of the Nation­al Secu­ri­ty Com­mis­sion on Arti­fi­cial Intel­li­gence (NSCAI), where mem­bers of the mil­i­tary, intel­li­gence com­mu­ni­ty and Sil­i­con Valley’s top firms argued for the need to reduce the use of “lega­cy sys­tems” in favor of AI-focused alter­na­tives as a nation­al secu­ri­ty imper­a­tive. Among those “lega­cy sys­tems” iden­ti­fied by the NSCAI were in-per­son doc­tor vis­its and even receiv­ing med­ical care from a human doc­tor, as opposed to an AI “doc­tor.” The NSCAI also argued for the removal of “reg­u­la­to­ry bar­ri­ers” that pre­vent these new tech­nolo­gies from replac­ing “lega­cy sys­tems.”

    Anoth­er notable board mem­ber, in dis­cussing Resilience’s intel­li­gence ties, is Drew Oet­ting. Oet­ting works for Cer­berus Cap­i­tal Man­age­ment, the firm head­ed by Steve Fein­berg who pre­vi­ous­ly led the President’s Intel­li­gence Advi­so­ry Board under the Trump admin­is­tra­tion. Cer­berus is notably the par­ent com­pa­ny of Dyn­Corp, a con­tro­ver­sial US nation­al secu­ri­ty con­trac­tor tied to numer­ous scan­dals, includ­ing scan­dals relat­ed to sex traf­fick­ing in con­flict zones. Oet­ting is also part of the CIA-linked Thorn NGO osten­si­bly focused on tack­ling child traf­fick­ing that was the sub­ject of a pre­vi­ous Unlim­it­ed Hang­out inves­ti­ga­tion.

    Oet­ting is also the co-founder of 8VC, a ven­ture cap­i­tal firm that is one of the main investors in Resilience. 8VC’s oth­er co-founder is Joe Lons­dale and Oet­ting “start­ed his career” as Lonsdale’s chief of staff. Lons­dale is the co-founder, along­side Peter Thiel and Alex Karp, of Palan­tir, a CIA front com­pa­ny and intel­li­gence con­trac­tor that is the suc­ces­sor to DARPA’s con­tro­ver­sial Total Infor­ma­tion Aware­ness (TIA) mass sur­veil­lance and data-min­ing pro­gram. In addi­tion, Oet­ting pre­vi­ous­ly worked for Bill Gates’ invest­ment fund.

    Also worth not­ing is the pres­ence of Joseph Robert Ker­rey, for­mer US Sen­a­tor for Nebras­ka and a for­mer mem­ber of the con­flict-of-inter­est-rid­den 9/11 Com­mis­sion, on Resilience’s board. Ker­rey is cur­rent­ly man­ag­ing direc­tor of Allen & Co., a New York invest­ment bank­ing firm which has host­ed an annu­al “sum­mer camp for bil­lion­aires” since 1983. Allen & Co. has long been a major play­er in net­works where orga­nized crime and intel­li­gence inter­sect, and is men­tioned repeat­ed­ly through­out my upcom­ing book One Nation Under Black­mail. For instance, Charles and Her­bert Allen, who ran the firm for decades, had con­sid­er­able busi­ness deal­ings with orga­nized crime king­pins and front­men for noto­ri­ous gang­sters like Mey­er Lan­sky, par­tic­u­lar­ly in the Bahamas. They were also busi­ness part­ners of Leslie Wexner’s men­tors A. Alfred Taub­man and Max Fish­er as well as asso­ciates of Earl Bri­an, one of the archi­tects of the PROMIS soft­ware scan­dal – which saw orga­nized crime and intel­li­gence net­works coop­er­ate to steal and then com­pro­mise the PROMIS soft­ware for black­mail and clan­des­tine intel­li­gence-gath­er­ing pur­pos­es. Allen & Co. was a major investor in Brian’s busi­ness inter­ests in the tech­nol­o­gy indus­try that Bri­an used in attempts to bank­rupt the devel­op­ers of PROMIS, Inslaw Inc. and to mar­ket ver­sions of PROMIS that had been com­pro­mised first by Israeli intel­li­gence and, lat­er, the CIA.

    In addi­tion to these intel­li­gence-linked indi­vid­u­als, the rest of Resilience’s board includes the for­mer CEO of the Bill & Melin­da Gates Foun­da­tion, Susan Desmond-Hell­mann; for­mer FDA Com­mis­sion­er and Pfiz­er board mem­ber, Scott Got­tlieb; two for­mer exec­u­tives at John­son & John­son; for­mer pres­i­dent and CEO of Teva Phar­ma­ceu­ti­cals North Amer­i­can branch, George Bar­rett; Cal­Tech pro­fes­sor and board mem­ber of Alpha­bet (i.e. Google) and Illu­mi­na, Frances Arnold; for­mer exec­u­tive at Genen­tech and Mer­ck, Patrick Yang; and Resilience CEO Rahul Singhvi./b>.

    To Boost or Not to Boost

    It is cer­tain­ly telling that the nor­mal­ly pub­lic­i­ty hun­gry Mod­er­na has said so lit­tle about its part­ner­ship with Resilience and that Resilience, despite its ambi­tious plans, has also avoid­ed the media lime­light. Con­sid­er­ing Moderna’s his­to­ry and Resilience’s con­nec­tions, there may be more to this part­ner­ship that meets the eye and con­cerned mem­bers of the pub­lic would do well to keep a very close eye on Resilience, its part­ner­ships, and the prod­ucts it is man­u­fac­tur­ing.

    ...

    ———-

    “RNA for Moderna’s Omi­cron Boost­er Man­u­fac­tured by CIA-Linked Com­pa­ny” by Whit­ney Webb; Unlim­it­ed Hang­out; 08/17/2022

    How­ev­er, unlike the company’s orig­i­nal COVID-19 vac­cine, the genet­ic mate­r­i­al, or mes­sen­ger RNA (mRNA), for this new vac­cine, includ­ing the new­ly for­mu­lat­ed genet­ic mate­r­i­al meant to pro­vide pro­tec­tion against the Omi­cron vari­ant, is being man­u­fac­tured, not by Mod­er­na, but by a rel­a­tive­ly new com­pa­ny that has received hard­ly any media atten­tion, despite its overt links to US intel­li­gence. Last Sep­tem­ber, it was qui­et­ly announced that a com­pa­ny called Nation­al Resilience (often referred to sim­ply as Resilience) would begin man­u­fac­tur­ing the mRNA for Mod­er­na COVID-19 vac­cine prod­ucts. Under the terms of the mul­ti-year agree­ment, “Resilience will pro­duce mRNA for the Mod­er­na COVID-19 vac­cine at its facil­i­ty in Mis­sis­sauga, Ontario, for dis­tri­b­u­tion world­wide.””

    A com­pa­ny that did­n’t exist at the start of the pan­dem­ic, Nation­al Resilience, is going to be man­u­fac­tur­ing the actu­al genet­ic mate­r­i­al used for the new round of Omi­cron-tar­get­ing mRNA boost­ers. The same boost­ers that were approved for pub­lic use based on mouse data. So we prob­a­bly should­n’t be sur­prised to learn that Nation­al Resilience is stacked with fig­ures from the intel­li­gence com­mu­ni­ty. Or that it entered into a part­ner­ship with the gov­ern­ment of Cana­da in July of 2021, with a $154.9 mil­lion gov­ern­ment invest­ment in Nation­al Resilience’s Ontario sub­sidiary. This is a com­pa­ny with ‘juice’ when it comes to be the biotech world and gov­ern­ment. And Mod­er­na seems to be eager to hand over this cru­cial part of the man­u­fac­tur­ing sup­ply chain to this new com­pa­ny bristling with gov­ern­ment insid­ers.

    This is a good time to recall the exten­sive sup­port from the US gov­ern­ment Mod­er­na has received over the years. That long-stand­ing gov­ern­ment part­ner­ship came to light after Mod­er­na sued Pfiz­er claim­ing patent infringe­ment on a broad-spec­trum beta­coro­n­avirus vac­cine, with Mod­er­na assert­ing that it was con­duct­ing human mRNA vac­cine tri­als with US researchers as far back as 2015. Also recall how Mod­er­na ‘returned the favor’ for this gov­ern­ment sup­port by fil­ing patents that left out prop­er acknowl­edg­ment for the gov­ern­ment sci­en­tists work result­ing in gov­ern­ment law­suits. Mod­er­na has­n’t exact­ly been lack­ing grand ambi­tions of its own, which makes its deci­sion to hand over its mRNA sup­ply chain for its still-grow­ing vac­cine busi­ness to this new com­pa­ny all the more note­wor­thy:

    ...
    Described by UK offi­cials as a “sharp­ened tool” in the nation’s con­tin­ued vac­ci­na­tion cam­paign, the refor­mu­lat­ed vac­cine com­bines the pre­vi­ous­ly approved COVID-19 vac­cine with a “vac­cine can­di­date” tar­get­ing the Omi­cron vari­ant BA.1. That vac­cine can­di­date has nev­er been pre­vi­ous­ly approved and has not been the sub­ject of inde­pen­dent study. The MHRA approved the vac­cine based on a sin­gle, incom­plete human tri­al cur­rent­ly being con­duct­ed by Mod­er­na. The com­pa­ny pro­mot­ed incom­plete data from that tri­al in com­pa­ny press releas­es in June and July. The study has yet to be pub­lished in a med­ical jour­nal or peer reviewed. No con­cerns have been raised by any reg­u­la­to­ry agency, includ­ing the MHRA, regard­ing Moderna’s past his­to­ry of engag­ing in sus­pect and like­ly ille­gal activ­i­ty in past prod­uct tri­als, includ­ing for its orig­i­nal COVID-19 vac­cine.

    ...

    Despite being in the ear­li­est stages of devel­op­ing its “rev­o­lu­tion­ary” man­u­fac­tur­ing capa­bil­i­ties, Nation­al Resilience entered into a part­ner­ship with the Gov­ern­ment of Cana­da in July of last year. Per that agree­ment, the Cana­di­an gov­ern­ment plans to invest CAD 199.2 mil­lion (about $154.9 mil­lion) into Nation­al Resilience’s Ontario-based sub­sidiary, Resilience Biotech­nolo­gies Inc. Most of those funds are des­tined for use in expand­ing the Ontario facil­i­ty that Resilience acquired last March and which is now man­u­fac­tur­ing the mRNA for Moderna’s COVID-19 prod­ucts. Canada’s Min­is­ter of Inno­va­tion, Sci­ence and Indus­try, François-Philippe Cham­pagne, assert­ed at the time that the invest­ment would “build future pan­dem­ic pre­pared­ness” and help “to grow Canada’s life sci­ence ecosys­tem as an engine for our eco­nom­ic recov­ery.” More recent­ly, in 2022, the com­pa­ny has announced a few new clients – Take­da, Opus Genet­ics and the US Depart­ment of Defense.
    ...

    Adding to the remark­able nature of Nation­al Resilience’s sud­den rise is the com­pa­ny’s state ambi­tion: It’s out to “rein­vent bio­man­u­fac­tur­ing” with a focus on cell and gene ther­a­pies, viral vec­tors, vac­cines, and pro­teins. And based on its suc­cess in cap­tur­ing the Mod­er­na mRNA sup­ply con­tract, and the com­pa­ny’s deep indus­try con­tacts, we have every rea­son to sus­pect the com­pa­ny to become a major play­er in those sec­tors too. The com­pa­ny clear­ly has both gov­ern­men­tal and cor­po­rate ‘juice’:

    ...
    Nation­al Resilience was found­ed rel­a­tive­ly recent­ly, in Novem­ber 2020, and describes itself as “a man­u­fac­tur­ing and tech­nol­o­gy com­pa­ny ded­i­cat­ed to broad­en­ing access to com­plex med­i­cines and pro­tect­ing bio­phar­ma­ceu­ti­cal sup­ply chains against dis­rup­tion.” It has since been build­ing “a sus­tain­able net­work of high-tech, end-to-end man­u­fac­tur­ing solu­tions with the aim to ensure the med­i­cines of today and tomor­row can be made quick­ly, safe­ly, and at scale.” It fur­therplans to “rein­vent bio­man­u­fac­tur­ing” and “democ­ra­tize access to med­i­cines,” name­ly gene ther­a­pies, exper­i­men­tal vac­cines and oth­er “med­i­cines of tomor­row.”

    In pur­suit of those goals, the com­pa­ny announced it would “active­ly invest in devel­op­ing pow­er­ful new tech­nolo­gies to man­u­fac­ture com­plex med­i­cines that are defin­ing the future of ther­a­peu­tics, includ­ing cell and gene ther­a­pies, viral vec­tors, vac­cines, and pro­teins.” It was found­ed with the report­ed inten­tion “to build a bet­ter sys­tem for man­u­fac­tur­ing com­plex med­i­cines to fight dead­ly dis­eases” as a way to improve post-COVID “pan­dem­ic pre­pared­ness.”
    ...

    All of these gov­ern­ment ties make the heavy over­lap between Nation­al Resilience’s ambi­tions of cre­at­ing “the world’s most advanced bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing ecosys­tem” and the kind of ‘gain-of-func­tion’ research that Pen­ta­gon-financed groups like the Eco­HealthAl­liance all the more intrigu­ing. All signs point towards Nation­al Resilience plan­ning on car­ry­ing out that kind of research, or at least facil­i­tat­ing that kind of research for oth­ers as part of the “Ama­zon Web Ser­vices for the biotech­nol­o­gy indus­try” ser­vice mod­el they are try­ing to build. All of the pieces are in place for the cre­ation of a ‘AWS for biotech’ gov­ern­ment-backed monop­oly. A gov­ern­ment-backed monop­oly that the gov­ern­ment-backed Mod­er­na appears to be more than will­ing to help bring into exis­tence:

    ...
    The com­pa­ny ini­tial­ly mar­ket­ed its man­u­fac­tur­ing capa­bil­i­ties as “the Resilience plat­form”, and offers prin­ci­pal­ly “RNA Modal­i­ties”, includ­ing RNA devel­op­ment for vac­cines, gene edit­ing and ther­a­peu­tics; and “Virus Pro­duc­tion”, includ­ing viral vec­tors, oncolyt­ic virus­es (i.e. a virus engi­neered to pref­er­en­tial­ly attack can­cer cells), virus­es for use in vac­cine devel­op­ment and gene-edit­ed virus­es for unspec­i­fied pur­pos­es. It is worth not­ing that, to date, many con­tro­ver­sial “gain-of-func­tion” exper­i­ments have jus­ti­fied mod­i­fy­ing virus­es for the same pur­pos­es as described by Nation­al Resilience’s Virus Pro­duc­tion capa­bil­i­ties. In addi­tion, Nation­al Resilience offers prod­uct for­mu­la­tions and oth­er modal­i­ties, such as bio­log­ics and cell ther­a­pies, to its clien­tele and the “Virus Pro­duc­tion” of its web­site has since been removed.

    ...

    Accord­ing to Nation­al Resilience’s exec­u­tives, the company’s ambi­tions appar­ent­ly go far beyond man­u­fac­tur­ing RNA and virus­es. For instance, Resilience CEO Rahul Singhvi has claimed that the com­pa­ny is seek­ing to build “the world’s most advanced bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing ecosys­tem.” Yet, Singhvi has declined to offer much in the way of specifics when it comes to exact­ly how the com­pa­ny plans to become the planet’s most elite bio­man­u­fac­tur­ing com­pa­ny.

    ...

    Singhvi has fur­ther insist­ed that Nation­al Resilience is “not a ther­a­peu­tics com­pa­ny, not a con­trac­tor and not a tools com­pa­ny” and instead aims “to boost pro­duc­tion using the new ther­a­peu­tic modal­i­ties” such as RNA-based treat­ments, which have become nor­mal­ized in the COVID-19 era. Where­as con­tract man­u­fac­tur­ers “are like kitchens, with pots and pans ready for any recipe,” “what we’re try­ing to do is fix the recipes,” Singhvi has explained. One mem­ber of Resilience’s board of direc­tors, for­mer FDA Com­mis­sion­er and Pfiz­er Board mem­ber Scott Got­tlieb, has described the com­pa­ny as seek­ing to act as the equiv­a­lent of Ama­zon Web Ser­vices for the biotech­nol­o­gy indus­try.

    Essen­tial­ly, Resilience bills itself as offer­ing solu­tions that will allow “futur­is­tic” med­i­cines, includ­ing mRNA vac­cines, to be pro­duced more quick­ly and more effi­cient­ly, with the appar­ent goal of monop­o­liz­ing cer­tain parts of the bio­man­u­fac­tur­ing process. It also appears poised to become the man­u­fac­tur­er of choice for mRNA vac­cines and exper­i­men­tal ther­a­peu­tics in the event of a future pan­dem­ic, which some pub­lic health “phil­an­thropists” like Bill Gates have said is immi­nent.
    ...

    Those deep gov­ern­ment ties also bring us to what could be the most omi­nous part of Nation­al Resilience’s busi­ness plans: offer­ing the ser­vice of sup­port­ing clients through the gov­ern­ment reg­u­la­to­ry process with a goal of get­ting prod­ucts to mar­ket more quick­ly. These ambi­tions are, of course, build­ing on the prece­dent of moves like the deci­sion to approve the lat­est mRNA boost­ers based entire­ly mouse data. In oth­er words, we should expect a lot more sto­ries about med­i­cines being approved based on mouse-tri­als-only if Nation­al Resilience is suc­cess­ful in deliv­er­ing these ser­vices:

    ...
    Per­haps the company’s most note­wor­thy ambi­tion relates to their claims that they sup­port clients through the gov­ern­ment reg­u­la­to­ry process. Giv­en the company’s empha­sis on speedy mass pro­duc­tion of exper­i­men­tal gene ther­a­pies, its stat­ed inten­tion of get­ting the “futur­is­tic” med­ical prod­ucts it man­u­fac­tures to mar­ket as quick­ly as pos­si­ble seems at odds with the slow­er, tra­di­tion­al reg­u­la­to­ry process­es. Indeed, one could eas­i­ly argue that the approvals of mRNA vac­cines for the first time in human his­to­ry dur­ing the COVID-19 cri­sis were only pos­si­ble because of the major relax­ing of reg­u­la­to­ry pro­ce­durse and safe­ty test­ing due to the per­ceived urgency of the sit­u­a­tion.

    Resilience seems intent on see­ing that phe­nom­e­non repeat itself. As pre­vi­ous­ly men­tioned, the com­pa­ny claims to allow for the set­ting and appli­ca­tion of “new stan­dards for man­u­fac­tur­ing cell ther­a­pies and gene ther­a­pies” and also says it plans to become a “tech­nol­o­gy-aggre­gat­ing stan­dards bear­er that helps ther­a­pies come to mar­ket more effi­cient­ly.” It pre­vi­ous­ly offered on its web­site “reg­u­la­to­ry sup­port” and “strat­e­gy con­sult­ing” to clients, sug­gest­ing that it would seek to medi­ate between clients and gov­ern­ment reg­u­la­tors in order to ful­fill its goal of hav­ing the prod­ucts it man­u­fac­tures tak­en to mar­ket more quick­ly. In addi­tion, upon launch, the com­pa­ny claimed it planned to obtain unspec­i­fied “reg­u­la­to­ry capa­bil­i­ties.” If so, it is cer­tain­ly notable that for­mer top Food and Drug Admin­is­tra­tion (FDA) offi­cials are either on the company’s board or, as will be not­ed short­ly, played a major role in the company’s cre­ation.

    ...

    And those grand ambi­tions of becom­ing the ‘AWS for biotech’ and a ‘bureau­cra­cy-whis­per­er’ that gets clients prod­ucts rapid­ly pushed through reg­u­la­to­ry review are made all the more alarm­ing when we learn that the idea for this com­pa­ny appar­ent­ly orig­i­nat­ed with Luciana Borio, then the vice pres­i­dent of In-Q-Tel. Nation­al Resilience does­n’t just have ‘juice’. It has CIA ‘juice’. You can’t get more con­nect­ed. This is the kind of com­pa­ny that could rede­fine this indus­try:

    ...
    Resilience was co-found­ed by Biotech ven­ture cap­i­tal­ist Robert Nelsen, who is known for lis­ten­ing “to science’s ear­li­est whis­pers, even when data are too ear­ly for just about any­one else.” Nelsen was one of the ear­li­est investors in Illu­mi­na, a Cal­i­for­nia-based gene-sequenc­ing hard­ware and soft­ware giant that is believed to cur­rent­ly dom­i­nate the field of genomics. As men­tioned in a pre­vi­ous Unlim­it­ed Hang­out inves­ti­ga­tion, Illu­mi­na is close­ly tied to the DARPA-equiv­a­lent of the Well­come Trust known as Well­come Leap, which is also focused on “futur­is­tic” and tran­shu­man­ist “med­i­cines.” Nelsen is now chair­man of Nation­al Resilience’s board, which is a “Who’s Who” of big play­ers from the US Nation­al Secu­ri­ty State, Big Phar­ma and Phar­ma-relat­ed “phil­an­thropy.”

    How­ev­er, while Nelsen has been giv­en much of the cred­it for cre­at­ing Resilience, he revealed in one inter­view that the idea for the com­pa­ny had actu­al­ly come from some­one else – Luciana Borio. In July of last year, Nelsen revealed that it was while talk­ing to Borio about “her work run­ning pan­dem­ic pre­pared­ness on the NSC [Nation­al Secu­ri­ty Coun­cil]” that had “helped lead to the launch of Nelsen’s $800 mil­lion bio­log­ics man­u­fac­tur­ing start­up Resilience.”

    At the time of their con­ver­sa­tion, Borio was the vice pres­i­dent of In-Q-tel, the ven­ture cap­i­tal arm of the CIA that has been used since its cre­ation in the ear­ly 2000s to found a num­ber of com­pa­nies, many of which act as Agency fronts. Pri­or to In-Q-Tel, she served as direc­tor for med­ical and biode­fense pre­pared­ness at the Nation­al Secu­ri­ty Coun­cil dur­ing the Trump admin­is­tra­tion and had pre­vi­ous­ly been the act­ing chief sci­en­tist at the FDA from 2015 to 2017.

    Borio is cur­rent­ly a senior fel­low for glob­al health at the Coun­cil on For­eign Rela­tions, a con­sul­tant to Gold­man Sachs, a mem­ber of the Bill Gates-fund­ed vac­cine alliance CEPI, and a part­ner at Nelsen’s ven­ture cap­i­tal firm ARCH Ven­ture Part­ners, which funds Resilience. Nelsen’s ARCH pre­vi­ous­ly fund­ed Nanosys, the com­pa­ny of the con­tro­ver­sial sci­en­tist Charles Lieber. Around the time of her con­ver­sa­tion with Nelsen that led to Resilience’s cre­ation, Borio was co-writ­ing a pol­i­cy paper for the Johns Hop­kins Cen­ter for Health Secu­ri­ty that rec­om­mend­ed link­ing COVID-19 vac­ci­na­tion sta­tus with food stamp pro­grams and rent assis­tance as a pos­si­ble means of coerc­ing cer­tain pop­u­la­tions to take the exper­i­men­tal vac­cine.

    Borio is hard­ly Resilience’s only In-Q-Tel con­nec­tion, as the CEO of In-Q-Tel, Chris Dar­by, sits on the company’s board of direc­tors. Dar­by is also on the board of direc­tors of the CIA Offi­cers Memo­r­i­al Foun­da­tion. Dar­by was also recent­ly a mem­ber of the Nation­al Secu­ri­ty Com­mis­sion on Arti­fi­cial Intel­li­gence (NSCAI), where mem­bers of the mil­i­tary, intel­li­gence com­mu­ni­ty and Sil­i­con Valley’s top firms argued for the need to reduce the use of “lega­cy sys­tems” in favor of AI-focused alter­na­tives as a nation­al secu­ri­ty imper­a­tive. Among those “lega­cy sys­tems” iden­ti­fied by the NSCAI were in-per­son doc­tor vis­its and even receiv­ing med­ical care from a human doc­tor, as opposed to an AI “doc­tor.” The NSCAI also argued for the removal of “reg­u­la­to­ry bar­ri­ers” that pre­vent these new tech­nolo­gies from replac­ing “lega­cy sys­tems.”
    ...

    Beyond Luciana Borio, Nation­al Resilience’s intel­li­gence ties include Drew Oet­ting of Steve Fein­berg’s Cer­berus Cap­i­tal Man­age­ment and Palan­tir’s Joe Lons­dale. It’s worth recall­ing at this point how Lons­dale played a key role in get­ting Sau­di mon­ey into Sil­i­con Val­ley. And while “Nation­al Resilience” clear­ly has close ties to the US gov­ern­ment, its con­tracts with Cana­da also make clear that it’s not exclu­sive­ly oper­at­ing in the US. You have to won­der how much Sau­di mon­ey Lons­dale will end up get­ting direct­ed into this ven­ture:

    ...
    Anoth­er notable board mem­ber, in dis­cussing Resilience’s intel­li­gence ties, is Drew Oet­ting. Oet­ting works for Cer­berus Cap­i­tal Man­age­ment, the firm head­ed by Steve Fein­berg who pre­vi­ous­ly led the President’s Intel­li­gence Advi­so­ry Board under the Trump admin­is­tra­tion. Cer­berus is notably the par­ent com­pa­ny of Dyn­Corp, a con­tro­ver­sial US nation­al secu­ri­ty con­trac­tor tied to numer­ous scan­dals, includ­ing scan­dals relat­ed to sex traf­fick­ing in con­flict zones. Oet­ting is also part of the CIA-linked Thorn NGO osten­si­bly focused on tack­ling child traf­fick­ing that was the sub­ject of a pre­vi­ous Unlim­it­ed Hang­out inves­ti­ga­tion.

    Oet­ting is also the co-founder of 8VC, a ven­ture cap­i­tal firm that is one of the main investors in Resilience. 8VC’s oth­er co-founder is Joe Lons­dale and Oet­ting “start­ed his career” as Lonsdale’s chief of staff. Lons­dale is the co-founder, along­side Peter Thiel and Alex Karp, of Palan­tir, a CIA front com­pa­ny and intel­li­gence con­trac­tor that is the suc­ces­sor to DARPA’s con­tro­ver­sial Total Infor­ma­tion Aware­ness (TIA) mass sur­veil­lance and data-min­ing pro­gram. In addi­tion, Oet­ting pre­vi­ous­ly worked for Bill Gates’ invest­ment fund.

    Also worth not­ing is the pres­ence of Joseph Robert Ker­rey, for­mer US Sen­a­tor for Nebras­ka and a for­mer mem­ber of the con­flict-of-inter­est-rid­den 9/11 Com­mis­sion, on Resilience’s board. Ker­rey is cur­rent­ly man­ag­ing direc­tor of Allen & Co., a New York invest­ment bank­ing firm which has host­ed an annu­al “sum­mer camp for bil­lion­aires” since 1983. Allen & Co. has long been a major play­er in net­works where orga­nized crime and intel­li­gence inter­sect, and is men­tioned repeat­ed­ly through­out my upcom­ing book One Nation Under Black­mail. For instance, Charles and Her­bert Allen, who ran the firm for decades, had con­sid­er­able busi­ness deal­ings with orga­nized crime king­pins and front­men for noto­ri­ous gang­sters like Mey­er Lan­sky, par­tic­u­lar­ly in the Bahamas. They were also busi­ness part­ners of Leslie Wexner’s men­tors A. Alfred Taub­man and Max Fish­er as well as asso­ciates of Earl Bri­an, one of the archi­tects of the PROMIS soft­ware scan­dal – which saw orga­nized crime and intel­li­gence net­works coop­er­ate to steal and then com­pro­mise the PROMIS soft­ware for black­mail and clan­des­tine intel­li­gence-gath­er­ing pur­pos­es. Allen & Co. was a major investor in Brian’s busi­ness inter­ests in the tech­nol­o­gy indus­try that Bri­an used in attempts to bank­rupt the devel­op­ers of PROMIS, Inslaw Inc. and to mar­ket ver­sions of PROMIS that had been com­pro­mised first by Israeli intel­li­gence and, lat­er, the CIA.

    In addi­tion to these intel­li­gence-linked indi­vid­u­als, the rest of Resilience’s board includes the for­mer CEO of the Bill & Melin­da Gates Foun­da­tion, Susan Desmond-Hell­mann; for­mer FDA Com­mis­sion­er and Pfiz­er board mem­ber, Scott Got­tlieb; two for­mer exec­u­tives at John­son & John­son; for­mer pres­i­dent and CEO of Teva Phar­ma­ceu­ti­cals North Amer­i­can branch, George Bar­rett; Cal­Tech pro­fes­sor and board mem­ber of Alpha­bet (i.e. Google) and Illu­mi­na, Frances Arnold; for­mer exec­u­tive at Genen­tech and Mer­ck, Patrick Yang; and Resilience CEO Rahul Singhvi..
    ...

    The sky is the lim­it for Nation­al Resilience. We’ll see how long it takes before the com­pa­ny man­ages to achieve some­thing close to a monop­oly sta­tus in dif­fer­ent parts of the biotech sup­ply-chain, both in the US and glob­al­ly. But it appears to be a mat­ter of time. Just as it also appears to be just a mat­ter of time before we are forced to learn nasty lessons about allow­ing com­pa­nies stacked with insid­ers to rush new biotech­nolo­gies to mar­ket. Nasty wild­ly prof­itable lessons that we will learn noth­ing from, no doubt.

    Posted by Pterrafractyl | October 27, 2022, 4:11 pm
  4. The new biva­lent mRNA COVID boost­ers — boost­ers designed with the spike pro­teins of both the orig­i­nal COVID19 strain as well as the new Omi­cron BA.5 vari­ant — haven’t been with­out their share of mys­ter­ies. For starters, there’s the fact that the genet­ic mate­r­i­al for the boost­ers is being pro­duced by a lit­tle-known recent­ly formed com­pa­ny, Nation­al Resilience, stacked with fig­ures from the intel­li­gence com­mu­ni­ty. Then there’s the deci­sion to issue the new mRNA biva­lent COVID boost­ers based on mouse-tri­al data, skip­ping the human safe­ty-tri­als. As we saw in that recent sto­ry about the ‘gain-of-func­tion’ exper­i­ments on hybrid COVID virus­es con­duct­ed at Boston Uni­ver­si­ty, the behav­ior of the mouse immune sys­tem can’t eas­i­ly be used as a proxy for how the human immune sys­tem might response. But the deci­sion to release the new biva­lent vac­cines based entire­ly on mouse data was made, with a goal of speed­ing up the deliv­ery of the new biva­lent vac­cine to the pub­lic in time for the fall, when COVID cas­es are expect­ed to rise again.

    That brings us to the fol­low­ing pair of arti­cles that should raise more ques­tions about the reg­u­la­to­ry process­es behind these deci­sions and the extent to which the pub­lic is reliant on data from Mod­er­na and Pfiz­er alone. First, it appears that these new biva­lent boost­ers don’t actu­al­ly demon­strate a sta­tis­ti­cal­ly sig­nif­i­cant improve­ment in anti­body lev­els over the orig­i­nal vac­cine. They aren’t worse than the orig­i­nal vac­cine, and even slight­ly bet­ter accord­ing to these stud­ies. Just not actu­al­ly bet­ter to the point of sta­tis­ti­cal sig­nif­i­cance.

    The ques­tion of whether or not the new biva­lent vac­cines are actu­al­ly bet­ter isn’t just an aca­d­e­m­ic area of inquiry. Again, the deci­sion to release the vac­cines based entire­ly on mouse data was ground­ed in a con­vic­tion that these were indeed bet­ter vac­cines for the newest strains and it was impor­tant to get them to the pub­lic as soon as pos­si­ble.

    But as we’re going to see, there are still mil­lions of read­i­ly avail­able orig­i­nal mRNA vac­cines that are sched­uled to expire in com­ing months. The mass expir­ing of those orig­i­nal vac­cines is obvi­ous­ly great new for Nation­al Resilience, which will have to fill in the gap with new vac­cines. But is it a good for the pub­lic? As the fol­low­ing arti­cle notes, The fed­er­al gov­ern­men­t’s sup­ply of the updat­ed boost­ers is on pace to run out next year as a result of a stalled COVID fund­ing request on Capi­tol Hill. And once those fed­er­al sup­plies are exhaust­ed (or expired), there will be no more free vac­cines in the US. With the GOP like­ly retak­ing con­trol of Con­gress next year it’s hard to imag­ine those stalled COVID fund­ing requests get­ting processed. Eschew­ing the orig­i­nal vac­cines that are about to expire while push­ing the new biva­lent vac­cines is basi­cal­ly a recipe for blow­ing through that fed­er­al sup­ply as soon as pos­si­ble. And that would be a poten­tial­ly jus­ti­fi­able deci­sion if the new biva­lent vac­cines are indeed more effec­tive. But if not, it’s just a recipe for pulling fed­er­al­ly-fund­ed free vac­cines out of the mar­ket soon­er rather than lat­er.

    That’s all part of the con­text of fol­low­ing pair of arti­cles. Two new stud­ies both sug­gest the biva­lent vac­cines basi­cal­ly per­form the same as the orig­i­nal. So how has the US fed­er­al gov­ern­ment respond­ed to those find­ings? Well, the White House­’s top COVID offi­cial, Dr. Ashish Jha , start­ed off by point­ing out that the two stud­ies had rel­a­tive­ly small sam­ple sizes. Jha then point­ed to upcom­ing stud­ies cur­rent­ly being con­duct­ed by Mod­er­na and Pfiz­er with more patients which he expects will indeed show a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence between the per­for­mance of the orig­i­nal vac­cine and the new biva­lent vac­cines. In oth­er words, the fed­er­al gov­ern­men­t’s response to these two new stud­ies is basi­cal­ly “let’s opti­misti­cal­ly wait for more data to come in before arriv­ing at con­clu­sions”.

    Jha’s opti­mism was­n’t entire­ly unfound­ed. As we’re going to see in the sec­ond arti­cle excerpt below, Pfiz­er announced two weeks ago that it found the new boost­ers increased the neu­tral­iz­ing anti­bod­ies sev­en days after the shot against the BA.4 and BA.5 sub­vari­ants in a study involv­ing 80 vol­un­teers. Both Pfiz­er and Mod­er­na are expect­ed to release more data on their stud­ies in com­ing weeks, with Mod­er­na expect­ing to have sta­tis­ti­cal­ly pow­ered data by the end of the year.

    But as Dan Barouch of Har­vard Med­ical School, one of the authors of one of the two new stud­ies that did­n’t find a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence between the old and new vac­cines, points out, find­ing a “sta­tis­ti­cal­ly sig­nif­i­cant” dif­fer­ence in the per­for­mance of the vac­cines isn’t actu­al­ly the same as find­ing a clin­i­cal­ly sig­nif­i­cant dif­fer­ence. Don’t for­get that these new stud­ies did indeed find high­er lev­els of anti­bod­ies get­ting gen­er­at­ed by the new biva­lent vac­cines. But not much high­er. The dif­fer­ence was small enough that, giv­en the rel­a­tive­ly small sam­ple size, the researchers could­n’t claim to have found a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence in the anti­body lev­els. Sim­ply increas­ing the num­ber of peo­ple in these stud­ies will increase the sta­tis­ti­cal sam­pling pow­er and make it more and more like­ly that a “sta­tis­ti­cal­ly sig­nif­i­cant” find­ing will be arrived at. But it’s entire­ly pos­si­ble that stud­ies with more peo­ple will sim­ply con­firm the rel­a­tive­ly small boost in anti­bod­ies from the biva­lent vac­cines. Is a rel­a­tive­ly small boost actu­al­ly a mean­ing­ful dif­fer­ence in a clin­i­cal sense? That’s the dis­tinc­tion Barouch was mak­ing between “sta­tis­ti­cal­ly sig­nif­i­cant” dif­fer­ences and “clin­i­cal­ly sig­nif­i­cant” dif­fer­ences.

    But there’s anoth­er angle to this sto­ry: it turns out recent­ly pub­lished data on mice showed the new biva­lent vac­cines to be quite promis­ing and con­fer much bet­ter pro­tec­tion than the orig­i­nal vac­cines. So at the same time ear­ly stud­ies are find­ing no dif­fer­ence between the orig­i­nal and new vac­cines in humans, we’re get­ting stud­ies on mice sug­gest­ing the new vac­cines are actu­al­ly much bet­ter. And this all for vac­cines that are already avail­able based entire­ly on mouse data under the assump­tion that doing so is impor­tant to get the enhanced pro­tec­tion from the new vac­cines avail­able to the pub­lic as soon as pos­si­ble. Over­all, it’s the kind of sto­ry that under­scores just how much gam­bling and guess­work is involved in this whole process. Gam­bles, guess­work, and repeat­ed assur­ances from the indus­try that every­thing is going great:

    CBS News

    White House still expects new COVID boost­ers will offer bet­ter pro­tec­tion, but two new stud­ies cast doubt

    By Alexan­der Tin
    Updat­ed on: Octo­ber 28, 2022 / 1:28 PM

    The White House­’s top COVID-19 offi­cial says he still expects the pro­tec­tion against the Omi­cron BA.5 vari­ant offered by the new COVID vac­cine boost­ers will be bet­ter than their pre­de­ces­sors, despite two stud­ies that appear to ques­tion that assump­tion. In an inter­view with CBS News, Dr. Ashish Jha also said he does not think anoth­er immi­nent change to the COVID boost­ers will be need­ed.

    Jha’s com­ments come after researchers found, in two small­er groups of vol­un­teers, data sug­gest­ing that the updat­ed boost­ers pro­vide only sim­i­lar but not supe­ri­or anti­body boosts against BA.5, com­pared to the orig­i­nal vac­cine for­mu­la.

    “I do think that the pro­tec­tion against infec­tion is going to be bet­ter than if you were get­ting the orig­i­nal pro­to­type boost­er,” Jha told CBS News.

    Jha said he was not sur­prised about the new study results and praised the two sci­en­tists — Dan Barouch of Har­vard Med­ical School and David Ho of Colum­bia Uni­ver­si­ty — who led each of the research teams behind the pre­lim­i­nary find­ings.

    How­ev­er, he pre­dict­ed that the “well-con­trolled tri­als” with “larg­er sam­ples” now under­way from vac­cine mak­ers could yield more favor­able results about the boost­ers’ per­for­mance.

    The stud­ies did turn up high­er anti­body respons­es after the updat­ed boost­er, Jha said, even if they were too small to be sta­tis­ti­cal­ly sig­nif­i­cant.

    “I expect we’re going to see at least that size ben­e­fit, prob­a­bly big­ger, in the Pfiz­er and Mod­er­na stud­ies,” Jha said.

    Jha’s com­ments are in line with expec­ta­tions pre­vi­ous­ly voiced by fed­er­al health offi­cials from across the Biden admin­is­tra­tion, who have argued for months that the updat­ed boost­ers being rolled out this fall would out­per­form the orig­i­nal for­mu­la­tions.

    In a state­ment, the FDA’s top vac­cines offi­cial said data “from larg­er, well con­trolled stud­ies that are not sub­ject to the same lim­i­ta­tion of these small­er stud­ies are expect­ed to be avail­able in the near future” and urged Amer­i­cans to seek out an updat­ed boost­er.

    “Addi­tion­al­ly, even mod­est improve­ments in vac­cine response to the biva­lent boost­ers could have impor­tant pos­i­tive con­se­quences on pub­lic health,” said a state­ment from Dr. Peter Marks, head of the FDA’s Cen­ter for Bio­log­ics Eval­u­a­tion and Research.

    The new boost­ers are known as “biva­lent” because they include both a com­po­nent tar­get­ing the orig­i­nal “pro­to­type” strain and anoth­er aimed at the BA.4 and BA.5 vari­ants.

    Ear­ly data from ani­mals test­ed with the new shots had been promis­ing. Pre­vi­ous ver­sions tar­get­ing oth­er strains tri­aled on humans also sug­gest­ed a biva­lent for­mu­la­tion would also offer at least an “incre­men­tal” improve­ment, health author­i­ties con­clud­ed.

    ...

    “Mod­est and non­signif­i­cant”

    But this week, two stud­ies seemed to upend those expec­ta­tions.

    “There was no sig­nif­i­cant dif­fer­ence in neu­tral­iza­tion of any SARS-CoV­‑2 vari­ant test­ed between indi­vid­u­als who received a fourth mono­va­lent vac­cine and those who received a fourth dose of a biva­lent vac­cine,” con­clud­ed one study, which has yet to be peer-reviewed, post­ed by the team led by Ho.

    Sci­en­tists drew blood from peo­ple rough­ly a month after they had got­ten the new shot and test­ed their anti­body respons­es against “pseudovirus­es” — essen­tial­ly mock-ups of dif­fer­ent vari­ants, includ­ing BA.5.

    Barouch’s team per­formed a sim­i­lar exper­i­ment against BA.5. They turned up only “a mod­est and non­signif­i­cant” improve­ment from the updat­ed boost­ers in their study, which has also yet to be peer-reviewed.

    “If that very small dif­fer­ence holds up in a much larg­er study, then a much larg­er study might actu­al­ly say that’s a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence. The ques­tion is, is it clin­i­cal­ly rel­e­vant? And I don’t believe that that lev­el of dif­fer­ence is clin­i­cal­ly rel­e­vant,” Barouch said in an inter­view.

    Barouch said a phe­nom­e­non called immune imprint­ing may turn out to be the cul­prit for the dis­ap­point­ing immune response to the updat­ed boost­er.

    Immune imprint­ing, also known as “orig­i­nal anti­genic sin,” refers to the the­o­ry that the ini­tial expo­sure peo­ple had to an ear­li­er strain of the virus — either from infec­tion or vac­ci­na­tion — may hin­der the abil­i­ty of the body to pro­duce anti­bod­ies to new strains.

    Both the vac­cine com­pa­nies and health offi­cials had pre­vi­ous­ly down­played the hur­dle this phe­nom­e­non might pose to the new shots.

    Barouch acknowl­edged there was a pos­si­bil­i­ty that respons­es against BA.5 could improve after more weeks fol­low­ing the updat­ed boost­er, but cau­tioned that we have seen anti­bod­ies decline in the months after pre­vi­ous mRNA COVID shots.

    His team also mea­sured anoth­er part of the immune response from T cells. Those were “not sub­stan­tial­ly” boost­ed by addi­tion­al shots from either the biva­lent or orig­i­nal for­mu­la­tions.

    “We all talk about anti­bod­ies, the focus has been on anti­bod­ies, but there’s two sides to the immune sys­tem: anti­bod­ies and T cells. And we believe that both are impor­tant for pro­tec­tion against severe dis­ease,” said Barouch.

    Updat­ing the vac­cines

    The new stud­ies come as the Biden admin­is­tra­tion is prepar­ing for key deci­sions about the coun­try’s COVID-19 vac­cine sup­ply.

    Mil­lions of dos­es of the orig­i­nal mono­va­lent vac­cine, which is still being used for pri­ma­ry series shots, are due to expire over the com­ing months. Boost­ers also still need to be green­light­ed for the youngest age group: chil­dren down to 6 months old.

    The fed­er­al gov­ern­men­t’s sup­ply of the updat­ed boost­ers is on pace to run out next year as a result of a stalled COVID fund­ing request on Capi­tol Hill, which will prompt a shift to the pri­vate mar­ket.

    ...

    “We will have our BA.4/5 data by year end and ours will be sta­tis­ti­cal­ly pow­ered,” Mod­er­na spokesper­son Chris Rid­ley said in an email.

    Rid­ley also point­ed to results from a pre­vi­ous biva­lent for­mu­la­tion by Mod­er­na tar­get­ed at the BA.1 vari­ant, which was pub­lished in The New Eng­land Jour­nal of Med­i­cine a few weeks ago.

    Pfiz­er and their Ger­man part­ner BioN­Tech announced find­ing “pos­i­tive ear­ly data” from their updat­ed shots ear­li­er this month. Pfiz­er spokesper­son Steve Dane­hy said they expect to “have addi­tion­al data in com­ing weeks” on the shots.

    “We’re going to want to make pol­i­cy deci­sions based on more defin­i­tive, larg­er stud­ies, which are com­ing soon,” Jha said.

    ———-

    “White House still expects new COVID boost­ers will offer bet­ter pro­tec­tion, but two new stud­ies cast doubt” By Alexan­der Tin; CBS News; 10/28/2022

    “How­ev­er, he pre­dict­ed that the “well-con­trolled tri­als” with “larg­er sam­ples” now under­way from vac­cine mak­ers could yield more favor­able results about the boost­ers’ per­for­mance.”

    Dr. Ashish Jha clear­ly was­n’t dis­suad­ed from the con­vic­tion that the new biva­lent vac­cines are bet­ter. We just need to wait for the stud­ies from the vac­cine man­u­fac­tur­ers. Jha went on to point out that the two new stud­ies did find that new boost­ers pro­duced high­er anti­body lev­els. They’re just not high­er enough to reach the lev­el of sta­tis­ti­cal sig­nif­i­cance based on the rel­a­tive­ly small sam­ple sizes. Jha even pre­dict­ed that Mod­er­na’s and Pfiz­er’s bet­ter-pow­ered stud­ies will show a larg­er rel­a­tive advan­tage to the new boost­ers. We’ll see, but that’s what Jha is pre­dict­ing, which isn’t sur­pris­ing since the fed­er­al gov­ern­men­t’s deci­sion to release the new boost­ers on mouse data alone was based on a near cer­tain con­vic­tion that the new boost­ers would be bet­ter:

    ...
    Jha said he was not sur­prised about the new study results and praised the two sci­en­tists — Dan Barouch of Har­vard Med­ical School and David Ho of Colum­bia Uni­ver­si­ty — who led each of the research teams behind the pre­lim­i­nary find­ings.

    ...

    The stud­ies did turn up high­er anti­body respons­es after the updat­ed boost­er, Jha said, even if they were too small to be sta­tis­ti­cal­ly sig­nif­i­cant.

    “I expect we’re going to see at least that size ben­e­fit, prob­a­bly big­ger, in the Pfiz­er and Mod­er­na stud­ies,” Jha said.

    Jha’s com­ments are in line with expec­ta­tions pre­vi­ous­ly voiced by fed­er­al health offi­cials from across the Biden admin­is­tra­tion, who have argued for months that the updat­ed boost­ers being rolled out this fall would out­per­form the orig­i­nal for­mu­la­tions.

    In a state­ment, the FDA’s top vac­cines offi­cial said data “from larg­er, well con­trolled stud­ies that are not sub­ject to the same lim­i­ta­tion of these small­er stud­ies are expect­ed to be avail­able in the near future” and urged Amer­i­cans to seek out an updat­ed boost­er.

    “Addi­tion­al­ly, even mod­est improve­ments in vac­cine response to the biva­lent boost­ers could have impor­tant pos­i­tive con­se­quences on pub­lic health,” said a state­ment from Dr. Peter Marks, head of the FDA’s Cen­ter for Bio­log­ics Eval­u­a­tion and Research.
    ...

    In addi­tion, it appears that data on mice also found that the new boost­ers trig­gered high­er anti­body respons­es. It’s going to be inter­est­ing to see how dif­fer­ent the study results on mice and humans end up being for these boost­ers as bet­ter-pow­ered stud­ies are report­ed:

    ...
    Ear­ly data from ani­mals test­ed with the new shots had been promis­ing. Pre­vi­ous ver­sions tar­get­ing oth­er strains tri­aled on humans also sug­gest­ed a biva­lent for­mu­la­tion would also offer at least an “incre­men­tal” improve­ment, health author­i­ties con­clud­ed.
    ...

    And Jha’s pre­dic­tion that the Mod­er­na and Pfiz­er stud­ies will show not just a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence but a larg­er dif­fer­ence between the old and new boost­ers isn’t just Jha voic­ing opti­mism. AS Dr. Barouch, the author of one of two new stud­ies, points out, a sta­t­i­cal­ly sig­nif­i­cant dif­fer­ence may not be a clin­i­cal­ly sig­nif­i­cant dif­fer­ence. Which means it’s entire­ly pos­si­ble future bet­ter-pow­ered stud­ies will indeed reveal a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence, but still not a clin­i­cal­ly sig­nif­i­cant dif­fer­ence:

    ...
    But this week, two stud­ies seemed to upend those expec­ta­tions.

    “There was no sig­nif­i­cant dif­fer­ence in neu­tral­iza­tion of any SARS-CoV­‑2 vari­ant test­ed between indi­vid­u­als who received a fourth mono­va­lent vac­cine and those who received a fourth dose of a biva­lent vac­cine,” con­clud­ed one study, which has yet to be peer-reviewed, post­ed by the team led by Ho.

    Sci­en­tists drew blood from peo­ple rough­ly a month after they had got­ten the new shot and test­ed their anti­body respons­es against “pseudovirus­es” — essen­tial­ly mock-ups of dif­fer­ent vari­ants, includ­ing BA.5.

    Barouch’s team per­formed a sim­i­lar exper­i­ment against BA.5. They turned up only “a mod­est and non­signif­i­cant” improve­ment from the updat­ed boost­ers in their study, which has also yet to be peer-reviewed.

    “If that very small dif­fer­ence holds up in a much larg­er study, then a much larg­er study might actu­al­ly say that’s a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence. The ques­tion is, is it clin­i­cal­ly rel­e­vant? And I don’t believe that that lev­el of dif­fer­ence is clin­i­cal­ly rel­e­vant,” Barouch said in an inter­view.
    ...

    And that dis­tinc­tion between sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ences and clin­i­cal­ly sig­nif­i­cant dif­fer­ences get at the heart of the ques­tion over whether or not the fed­er­al gov­ern­ment is just wast­ing and throw­ing away the mil­lions of orig­i­nal vac­cines that are slat­ed to expire in com­ing months. With the fed­er­al gov­ern­ment get­ting out of the busi­ness of pro­vid­ing free vac­cines next year, this is arguably a deci­sion to toss away usable vac­cines and has­ten the end of freely avail­able vac­cines:

    ...
    The new stud­ies come as the Biden admin­is­tra­tion is prepar­ing for key deci­sions about the coun­try’s COVID-19 vac­cine sup­ply.

    Mil­lions of dos­es of the orig­i­nal mono­va­lent vac­cine, which is still being used for pri­ma­ry series shots, are due to expire over the com­ing months. Boost­ers also still need to be green­light­ed for the youngest age group: chil­dren down to 6 months old.

    The fed­er­al gov­ern­men­t’s sup­ply of the updat­ed boost­ers is on pace to run out next year as a result of a stalled COVID fund­ing request on Capi­tol Hill, which will prompt a shift to the pri­vate mar­ket.
    ...

    Inter­est­ing­ly, Barouch points to a known bio­log­i­cal phe­nom­e­na that could explain why the biva­lent vac­cines don’t improve respons­es as pre­dict­ed: “orig­i­nal anti­genic sin”, or the the­o­ry that the body tends to remem­ber the orig­i­nal ver­sion of a virus bet­ter than it adapts to new­er ver­sions. Note how Mod­er­na, Pfiz­er, and health offi­cials appeared to down­play this the­o­ry. It’s going to be very inter­est­ing to see if this the­o­ry pans out:

    ...
    Barouch said a phe­nom­e­non called immune imprint­ing may turn out to be the cul­prit for the dis­ap­point­ing immune response to the updat­ed boost­er.

    Immune imprint­ing, also known as “orig­i­nal anti­genic sin,” refers to the the­o­ry that the ini­tial expo­sure peo­ple had to an ear­li­er strain of the virus — either from infec­tion or vac­ci­na­tion — may hin­der the abil­i­ty of the body to pro­duce anti­bod­ies to new strains.

    Both the vac­cine com­pa­nies and health offi­cials had pre­vi­ous­ly down­played the hur­dle this phe­nom­e­non might pose to the new shots.

    Barouch acknowl­edged there was a pos­si­bil­i­ty that respons­es against BA.5 could improve after more weeks fol­low­ing the updat­ed boost­er, but cau­tioned that we have seen anti­bod­ies decline in the months after pre­vi­ous mRNA COVID shots.

    His team also mea­sured anoth­er part of the immune response from T cells. Those were “not sub­stan­tial­ly” boost­ed by addi­tion­al shots from either the biva­lent or orig­i­nal for­mu­la­tions.

    “We all talk about anti­bod­ies, the focus has been on anti­bod­ies, but there’s two sides to the immune sys­tem: anti­bod­ies and T cells. And we believe that both are impor­tant for pro­tec­tion against severe dis­ease,” said Barouch.
    ...

    Final­ly, note that Mod­er­na is pre­dict­ing its sta­tis­ti­cal­ly robust stud­ies by the end of the year. Pfiz­er already had some ini­tial pos­i­tive reports:

    ...
    “We will have our BA.4/5 data by year end and ours will be sta­tis­ti­cal­ly pow­ered,” Mod­er­na spokesper­son Chris Rid­ley said in an email.

    Rid­ley also point­ed to results from a pre­vi­ous biva­lent for­mu­la­tion by Mod­er­na tar­get­ed at the BA.1 vari­ant, which was pub­lished in The New Eng­land Jour­nal of Med­i­cine a few weeks ago.

    Pfiz­er and their Ger­man part­ner BioN­Tech announced find­ing “pos­i­tive ear­ly data” from their updat­ed shots ear­li­er this month. Pfiz­er spokesper­son Steve Dane­hy said they expect to “have addi­tion­al data in com­ing weeks” on the shots.

    “We’re going t want to make pol­i­cy deci­sions based on more defin­i­tive, larg­er stud­ies, which are com­ing soon,” Jha said.
    ...

    Will Mod­er­na actu­al­ly deliv­er that larg­er study on time? And will the pub­lic get to see all of the rel­e­vant data or will we just be asked to trust them? We’ll see.

    So let’s take a clos­er look at that ear­ly report from Pfiz­er. As we’re going to see, while the com­pa­ny has excit­ed­ly tout­ed the rel­a­tive­ly high­er anti­body lev­els that its new biva­lent vac­cine appeared to induce in a tri­al of 80 vol­un­teers, that com­pa­ny has yet to pub­licly release effi­ca­cy data. That data is pre­sum­ably com­ing. But it’s hard to get super excit­ed with only 80 peo­ple. That’s not exact­ly a huge sta­tis­ti­cal­ly robust sam­ple, espe­cial­ly when you con­sid­er­ing all the dif­fer­ent demo­graph­ic groups those 80 peo­ple could fall under. It sounds like Pfiz­er just broke it into two groups: ages 18–55, and 55+. So it was real­ly just ~40 peo­ple in each of those groups. Again, not exact­ly huge. So it’s going to be very inter­est­ing to see the details that Pfiz­er even­tu­al­ly releas­es on its full study. But the fact that they only have 80 peo­ple rais­es the pos­si­bil­i­ty that we’re going to see results from Pfiz­er and Mod­er­na that are very dif­fer­ent from these oth­er two stud­ies and yet don’t actu­al­ly have that much more sta­tis­ti­cal pow­er behind them. What will reg­u­la­tors do in that case?:

    Bloomberg

    Pfiz­er Says Boost­er Lifts Anti­bod­ies for Omi­cron Vari­ants

    * Com­pa­nies release ear­ly anti­body data on mod­i­fied vac­cine
    * Amid slow boost­er cam­paign, Amer­i­cans await effi­ca­cy data

    By Marthe Four­cade and Riley Grif­fin
    Octo­ber 13, 2022 at 6:18 AM CDT
    Updat­ed on Octo­ber 13, 2022 at 8:42 AM CDT

    Pfiz­er Inc. and its Ger­man vac­cine part­ner said their boost­er tai­lored to the lat­est omi­cron vari­ants raised more anti­bod­ies against the dom­i­nant strains of Covid-19 when com­pared with the orig­i­nal shot designed to fight the form of the virus.

    Blood from 80 vol­un­teers col­lect­ed sev­en days after the boost­er shot showed an increase in neu­tral­iz­ing anti­bod­ies against the BA.4 and BA.5 sub­vari­ants in a study, Pfiz­er and BioN­Tech SE said in a state­ment Thurs­day.

    The vac­cines were autho­rized with­out data show­ing their per­for­mance in humans. Pfiz­er and BioN­Tech plan to release addi­tion­al data in com­ing weeks mea­sur­ing immune respons­es one month fol­low­ing admin­is­tra­tion of the new biva­lent boost­er. They have not shared data on the shot’s effi­ca­cy, which would offer a bet­ter mea­sure of pro­tec­tion against wide­ly cir­cu­lat­ing vari­ants.

    “While we expect more mature immune-response data from the clin­i­cal tri­al of our omi­cron BA.4/BA.5‑adapted biva­lent vac­cine in the com­ing weeks, we are pleased to see encour­ag­ing respons­es just one week after vac­ci­na­tion in younger and old­er adults,” Pfiz­er Chief Exec­u­tive Albert Bourla said in the state­ment. “These ear­ly data sug­gest that our biva­lent vac­cine is antic­i­pat­ed to pro­vide bet­ter pro­tec­tion against cur­rent­ly cir­cu­lat­ing vari­ants than the orig­i­nal vac­cine, and poten­tial­ly help to curb future surges in cas­es this win­ter.”

    The vac­cine part­ners stud­ied two cohorts that had been giv­en the new vac­cine: one includ­ed those ages 18 to 55, and the oth­er includ­ing those 55 and up. The old­er cohort that demon­strat­ed a weak­er anti­body response against BA.4/BA.5 com­pared to the younger cohort, the com­pa­nies said.

    The US fall boost­er cam­paign has thus far fal­tered. Only 11.5 mil­lion Amer­i­cans have been admin­is­tered a new­ly mod­i­fied vac­cine from Pfiz­er-BioN­Tech or Mod­er­na Inc., a frac­tion com­pared to pre­vi­ous boost­er cam­paigns. On Wednes­day, US reg­u­la­tors expand­ed access to the new biva­lent boost­er shots to include chil­dren ages 5 and up.

    ...

    ———–

    “Pfiz­er Says Boost­er Lifts Anti­bod­ies for Omi­cron Vari­ants” By Marthe Four­cade and Riley Grif­fin; Bloomberg; 10/13/2022

    Blood from 80 vol­un­teers col­lect­ed sev­en days after the boost­er shot showed an increase in neu­tral­iz­ing anti­bod­ies against the BA.4 and BA.5 sub­vari­ants in a study, Pfiz­er and BioN­Tech SE said in a state­ment Thurs­day.”

    80 vol­un­teers is pre­sum­ably larg­er than the two new­ly released stud­ies that found no dif­fer­ence between the orig­i­nal and new boost­ers. And yet 80 peo­ple isn’t like some vast pool. And the small­er the dif­fer­ence you’re try­ing to mea­sure the greater the sta­tis­ti­cal pow­er that is required.

    But also note that Pfiz­er isn’t real­ly tell us how much high­er the anti­body lev­els are that are elicit­ed by the new vac­cine vs the orig­i­nal. Just that they are high­er. Well, that’s what those oth­er stud­ies found too: the new vac­cines did stim­u­late high­er anti­body lev­els. But not much high­er. The dif­fer­ence was so small that they could­n’t claim sta­tis­ti­cal sig­nif­i­cance. So is that what Pfiz­er found too? Or did the com­pa­ny see much greater dif­fer­ence? We have no idea. Just as we have no idea about the actu­al effi­ca­cy of the vac­cine. Pfiz­er isn’t report­ing that:

    ...
    The vac­cines were autho­rized with­out data show­ing their per­for­mance in humans. Pfiz­er and BioN­Tech plan to release addi­tion­al data in com­ing weeks mea­sur­ing immune respons­es one month fol­low­ing admin­is­tra­tion of the new biva­lent boost­er. They have not shared data on the shot’s effi­ca­cy, which would offer a bet­ter mea­sure of pro­tec­tion against wide­ly cir­cu­lat­ing vari­ants.
    ...

    If Pfiz­er find­ing one ‘break­through’ infec­tion after anoth­er? That might explain why it does­n’t want to report on the effi­ca­cy.

    Final­ly, notice the glar­ing data point miss­ing in all of this: non-mRNA COVID vac­cines. Sure, they exist. The J&J boost­er is still hypo­thet­i­cal­ly avail­able despite the US gov­ern­ments clear attempts to push every­one onto the mRNA vac­cines. And the Novavax boost­er just received approval. But almost no one is get­ting those shots. Where are the stud­ies com­par­ing these vac­cine tech­nolo­gies? Don’t for­get how the J&J vac­cine appeared to be the best per­former for long-term effi­ca­cy back in May right when the US gov­ern­ment advised against its use based on a rare blood­clot­ting issue. How can it be that there’s so lit­tle inter­est­ing in these com­par­isons? Who knows, but that’s the state of affairs. There is a clear and very strong gov­ern­men­tal pref­er­ence for the mRNA vac­cines over­all oth­er options. That’s abun­dant­ly clear. What isn’t clear is why that pref­er­ence exists and it’s get­ting less and less clear with each study, or lack there­of.

    Posted by Pterrafractyl | November 2, 2022, 4:44 pm
  5. Reg­u­la­to­ry cap­ture has long been a fea­ture of how the US gov­ern­ment oper­ates. It’s one of the fun fact about how the US works that has been loom­ing over the devel­op­ment of the COVID vac­cines from the begin­ning. Because as we’ve seen, the US gov­ern­ment has­n’t just been an enthu­si­as­tic cham­pi­on of the exper­i­ment mRNA vac­cine tech­nol­o­gy devel­oped by Mod­er­na. They’ve been part­ners in devel­op­ing the tech­nol­o­gy for years, with bil­lions of dol­lars in US tax­pay­er dol­lars hav­ing gone into this research. It’s a fea­ture of the his­to­ry of the devel­op­ment of these new tech­nolo­gies that becomes unfor­tu­nate­ly top­i­cal when­ev­er there’s a new sto­ry rais­ing ques­tions about the safe­ty or effec­tive­ness of the vac­cines. Sto­ries like how the new biva­lent covid boost­ers were approved based large­ly on mouse tri­als. Tiny mouse tri­als. Or then there’s sto­ries like how the FDA basi­cal­ly killed the John­son & John­son vac­cine based on a very rare side-effect, despite data show­ing the J&J vac­cine was out­per­form­ing the oth­er vac­cines when it came to the long-term dura­bil­i­ty of the anti­bod­ies.

    So it should come as lit­tle sur­prise at this point to learn that the advi­so­ry pan­els the FDA and CDC relied on to pro­vide inde­pen­dent advice on whether or not to approve the new new COVID mRNA boost­ers are now pissed at the FDA and CDC. And Mod­er­na. Because as the fol­low­ing piece describes, it appears that the FDA, CDC, and Mod­er­na all col­lud­ed to with­hold data from these advi­so­ry pan­els the Mod­er­na had already gath­ered indi­cat­ing that the biva­lent COVID boost­ers are pos­si­bly less effec­tive at pre­vent an infec­tion than the orig­i­nal mRNA vac­cine for­mu­la­tion.

    Yep, first the FDA held a day-long meet­ing on June 28 with a pan­el of inde­pen­dent experts about the new boost­ers. The pres­i­dent of Mod­er­na was also invit­ed to present to the pan­el and shared the results of a new Mod­er­na study that had just been preprint­ed (non-peer reviewed) three days before the meet­ing. The study showed the new biva­lent vac­cine elicit­ed high­er anti­body lev­els. But also high­er infec­tion rates. The high­er anti­body lev­els were excit­ed­ly shared to the pan­el. Noth­ing about the high­er infec­tion rates was shared.

    So why did­n’t the FDA share this info about high­er infec­tion rates with the pan­el? The FDA was aware of Mod­er­na’s preprint­ed study, after all. We’ll we’re told that the FDA just did­n’t have enough time to review it. That’s the excuse giv­en for how Mod­er­na’s pres­i­dent was allowed to selec­tive­ly share results with the pan­el and the FDA leav­ing the pan­elists in the dark.

    The FDA ulti­mate­ly approved the biva­lent boost­ers on August 31. The next day, the CDC held an inde­pen­dent pan­el of its own to review the new biva­lent boost­ers. Again, peo­ple from Mod­er­na were there to selec­tive­ly present how the new boost­ers result­ed in high­er anti­body lev­els while leav­ing out the data about the high­er infec­tion rates entire­ly. On Sep­tem­ber 13, the FDA final­ly pub­lished the data it based its approval on, includ­ing the infec­tion data. So the FDA only pub­licly released the data from Mod­er­na show­ing pos­si­bly low­er effi­ca­cy for the new boost­ers only after the CDC’s pan­el gave its own stamp of approval with­out know­ing about the low­er effi­ca­cy find­ings.

    So what was the CDC’s excuse for keep­ing the pan­el in the dark? Well, accord­ing to the CDC spokesper­son, the “CDC was aware” of the data that would lat­er be pub­lished in The New Eng­land Jour­nal of Med­i­cine. Also, they added that assess­ing infec­tions was an “explorato­ry objec­tive of the study,” which was “not designed to assess vac­cine effec­tive­ness.” It’s not exact­ly a com­pelling excuse. Final­ly, they point­ed out that in assess­ing infec­tions, “researchers used dif­fer­ent dura­tions and points in time among a very small group of peo­ple,” and because of the lim­i­ta­tions of the data, it was not fea­tured at the meet­ing. In oth­er words, the Mod­er­na study was poor­ly-pow­ered crap.

    Which is was by all indi­ca­tions. And that’s part of the sto­ry here: Mod­er­na’s poor­ly-pow­ered crap study was appar­ent­ly fine for use when it increased the chances of the vac­cines get­ting approved. But when it comes to the data show­ing reduced effec­tive­ness we can just ignore it because of the poor sta­tis­ti­cal pow­er. It’s all quite con­ve­nient. Con­ve­nient for Mod­er­na and any Mod­er­na super-fans that inhab­it the fed­er­al reg­u­la­to­ry bureau­cra­cy. As Dr. Paul Offit, one of the inde­pen­dent experts who is now livid over this scan­dal, put it, his faith in the whole approval process has been shak­en. Which should raise plen­ty of ques­tions for the rest of us:

    CNN

    FDA vac­cine advis­ers ‘dis­ap­point­ed’ and ‘angry’ that ear­ly data about new Covid-19 boost­er shot wasn’t pre­sent­ed for review last year

    By Eliz­a­beth Cohen and Nao­mi Thomas, CNN
    Pub­lished 6:35 AM EST, Wed Jan­u­ary 11, 2023

    CNN — Some vac­cine advis­ers to the fed­er­al gov­ern­ment say they’re “dis­ap­point­ed” and “angry” that gov­ern­ment sci­en­tists and the phar­ma­ceu­ti­cal com­pa­ny Mod­er­na didn’t present a set of infec­tion data on the company’s new Covid-19 boost­er dur­ing meet­ings last year when the advis­ers dis­cussed whether the shot should be autho­rized and made avail­able to the pub­lic.

    That data sug­gest­ed the pos­si­bil­i­ty that the updat­ed boost­er might not be any more effec­tive at pre­vent­ing Covid-19 infec­tions than the orig­i­nal shots.

    The data was ear­ly and had many lim­i­ta­tions, but sev­er­al advis­ers told CNN that they were con­cerned about a lack of trans­paren­cy.

    US tax­pay­ers spent near­ly $5 bil­lion on the new boost­er, which has been giv­en to more than 48.2 mil­lion peo­ple in the US.

    “I was angry to find out that there was data that was rel­e­vant to our deci­sion that we didn’t get to see,” said Dr. Paul Offit, a mem­ber of the Vac­cines and Relat­ed Bio­log­i­cal Prod­ucts Advi­so­ry Com­mit­tee, a group of exter­nal advis­ers that helps the FDA make vac­cine deci­sions. “Deci­sions that are made for the pub­lic have to be made based on all avail­able infor­ma­tion – not just some infor­ma­tion, but all infor­ma­tion.”

    At a meet­ing of this FDA advi­so­ry group in June and a meet­ing in Sep­tem­ber of a pan­el that advis­es the US Cen­ters for Dis­ease Con­trol and Pre­ven­tion, the experts were pre­sent­ed with reams of infor­ma­tion indi­cat­ing that the new vac­cine worked bet­ter than the one already on shelves, accord­ing to a review of videos and tran­scripts of those meet­ings and slide pre­sen­ta­tions made by Mod­er­na, CDC and FDA offi­cials.

    That data – called immuno­genic­i­ty data – was based on blood work done on study par­tic­i­pants to assess how well each vac­cine elicit­ed anti­bod­ies that fight off the Omi­cron strain of the virus that caus­es Covid-19.

    The data that was not pre­sent­ed to the experts looked at actu­al infec­tions: who caught Covid-19 and who did not.

    It found that 1.9% of the study par­tic­i­pants who received the orig­i­nal boost­er became infect­ed. Among those who got the updat­ed biva­lent vac­cine – the one that sci­en­tists hoped would work bet­ter – a high­er per­cent­age, 3.2%, became infect­ed. Both ver­sions of the shot were found to be safe.

    This infec­tion data was far from com­plete. The num­ber of study sub­jects who became infect­ed was very small, and both the patients and the researchers were aware of who was get­ting the orig­i­nal shot and who was get­ting the new boost­er.

    Despite these imper­fec­tions, the data was includ­ed in a preprint study that was post­ed online in June, again in Sep­tem­ber in an FDA doc­u­ment and then lat­er that month in a top med­ical jour­nal – and advis­ers to the FDA and the CDC said the data should have been shared with them, too.

    “It’s not a group of chil­dren. We under­stand how to inter­pret these results,” said Dr. Eric Rubin, a mem­ber of the FDA vac­cine advi­so­ry com­mit­tee.

    The six FDA and CDC advis­ers inter­viewed by CNN said that this infec­tion data wouldn’t have changed how they vot­ed, because the data had such lim­i­ta­tions, but it still should have been pre­sent­ed to them.

    “There should always be full trans­paren­cy,” said Dr. Arnold Mon­to, a pro­fes­sor of epi­demi­ol­o­gy at the Uni­ver­si­ty of Michi­gan School of Pub­lic Health and act­ing chair of the FDA advis­ers’ group. “These data should not be dis­missed. They are ear­ly, but they indi­cate that we need to look at them and see what their val­ue is.”

    Dr. Pablo Sanchez, a mem­ber of the CDC’s pan­el, called the Advi­so­ry Com­mit­tee on Immu­niza­tion Prac­tices, said that if the data “was looked at as part of the study, it should have been pre­sent­ed to the advis­ers pri­or to their deci­sion.”

    The FDA and the CDC con­vene their advi­so­ry board meet­ings and make pre­sen­ta­tions to the advis­ers. At last year’s meet­ings, Mod­er­na exec­u­tives made pre­sen­ta­tions, as well. The advis­ers then make their rec­om­men­da­tions to the agen­cies, and the agen­cies decide whether to autho­rize the shots and rec­om­mend them to the pub­lic.

    Mod­er­na spokesman Christo­pher Rid­ley said in an email to CNN that the com­pa­ny shared the infec­tion data with the FDA and post­ed the study man­u­script before the agency’s pan­el meet­ing in June “in response to requests that we share an update from the ongo­ing study.”

    That study preprint was post­ed online June 25, three days before the FDA advis­ers met.

    Michael Fel­ber­baum, an FDA spokesman, told CNN in an email that “the FDA received the preprint less than a day pri­or to the advi­so­ry com­mit­tee meet­ing,” and “the infor­ma­tion was there­fore not pro­vid­ed in an ade­quate time­frame for it to be includ­ed in the agency’s meet­ing mate­ri­als, and gen­er­al­ly the FDA only dis­cuss­es data at advi­so­ry com­mit­tee meet­ings that the agency has had the oppor­tu­ni­ty to sub­stan­tive­ly review.”

    “Numer­ous stud­ies sup­port the find­ing that the COVID-19 vac­cines remain the best defense against the most dev­as­tat­ing con­se­quences of COVID-19 such as hos­pi­tal­iza­tion and death, and that the updat­ed vac­cines may help pro­vide bet­ter pro­tec­tion against the cur­rent­ly cir­cu­lat­ing vari­ants,” Fel­ber­baum wrote.

    He added that “through­out the pan­dem­ic, the FDA has remained as trans­par­ent as pos­si­ble regard­ing its process­es and deci­sion-mak­ing regard­ing the COVID-19 vac­cines” and that Mod­er­na could have cho­sen to present the data at the FDA advi­so­ry com­mit­tee meet­ing.

    Kris­ten Nord­lund, a CDC spokes­woman, said that “due to the many lim­i­ta­tions involv­ing this clin­i­cal data, it was not fea­tured” in the CDC’s advi­so­ry com­mit­tee dis­cus­sion.

    Empha­sis on trans­paren­cy

    The advis­ers said there are three main rea­sons why it mat­ters that the infec­tion data was not pre­sent­ed to them.

    One, they said, is the poten­tial impact of their deci­sion: If Amer­i­cans were going to be get­ting these shots, all avail­able data should be brought to the table for con­sid­er­a­tion.

    Two, the advi­so­ry com­mit­tee meet­ings are streamed live online, and reg­u­la­to­ry agen­cies around the world use the infor­ma­tion to help make deci­sions about vac­cines in their coun­tries.

    Three, they stressed that trans­paren­cy is impor­tant. The pub­lic doesn’t wit­ness con­ver­sa­tions among FDA offi­cials or between agency offi­cials and phar­ma­ceu­ti­cal com­pa­ny exec­u­tives, but they do get to watch the advi­so­ry pan­els’ pro­ceed­ings.

    ...

    Infec­tion data not includ­ed in pre­sen­ta­tions by FDA and Mod­er­na

    Last sum­mer, as the FDA’s and CDC’s out­side advis­ers con­sid­ered the updat­ed boost­ers, the stakes were high. They knew that in just a mat­ter of months, win­ter would be approach­ing, and Covid rates could spike. They also knew the orig­i­nal vac­cine was get­ting less effec­tive with each new vari­ant and that the addi­tion of the Omi­cron strain in the updat­ed boost­er might help bat­tle the virus.

    The FDA advis­ers – 21 vot­ing mem­bers, includ­ing infec­tious dis­ease experts and vac­ci­nol­o­gists from Stan­ford, the Uni­ver­si­ty of Penn­syl­va­nia and Har­vard – met for a full day on June 28.

    Dr. Stephen Hoge, the pres­i­dent of Mod­er­na, made a pre­sen­ta­tion to the advis­ers and fre­quent­ly referred to infor­ma­tion from the preprint study that had been post­ed three days before. The study was fund­ed by Mod­er­na and led by com­pa­ny sci­en­tists, and it had not been sub­ject­ed to peer review or pub­lished in a med­ical jour­nal.

    The data Hoge shared with the advis­ers demon­strat­ed that blood tests on about 800 study par­tic­i­pants indi­cat­ed that the new biva­lent boost­er was “supe­ri­or” at increas­ing anti­bod­ies to the Omi­cron vari­ant com­pared with the orig­i­nal vac­cine.

    Hoge did not men­tion anoth­er part of the study that cast a less-pos­i­tive light on the updat­ed shot.

    In that part, the researchers gave some par­tic­i­pants the exist­ing vac­cine and oth­er par­tic­i­pants the updat­ed boost­er, and then they kept track of who became infect­ed with Covid-19.

    Among the hun­dreds of par­tic­i­pants who received the orig­i­nal vac­cine and showed no evi­dence of a pri­or Covid-19 infec­tion, over the peri­od of the small study, 1.9% became infect­ed. Among the hun­dreds who received the new biva­lent vac­cine, a high­er per­cent­age, 3.2%, became infect­ed. The preprint did not indi­cate whether these find­ings were sta­tis­ti­cal­ly sig­nif­i­cant.

    A 22-page FDA brief­ing doc­u­ment giv­en to the advis­ers did not men­tion this infec­tion data.

    Dr. Jer­ry Weir, direc­tor of the Divi­sion of Viral Prod­ucts at the FDA’s Office of Vac­cines Research and Review, also did not men­tion the infec­tion data in his pre­sen­ta­tion to the advis­ers.

    At the end of the June 28 meet­ing, the FDA advis­ers vot­ed 19–2 to rec­om­mend the inclu­sion of an Omi­cron vari­ant for the Covid-19 boost­er vac­cine. Offit, a pro­fes­sor of vac­ci­nol­o­gy at the Perel­man School of Med­i­cine at the Uni­ver­si­ty of Penn­syl­va­nia, and Dr. Hen­ry Bern­stein, a pro­fes­sor of pedi­atrics at the Zuck­er School of Med­i­cine at Hofstra/Northwell in New York, vot­ed in oppo­si­tion.

    Over the next month, the US gov­ern­ment announced agree­ments to pur­chase the biva­lent boost­er from Pfiz­er and Mod­er­na: a con­tract for $3.2 bil­lion with Pfiz­er and for $1.74 bil­lion with Mod­er­na.

    Lim­i­ta­tions of Moderna’s infec­tion data

    The infec­tion data that wasn’t includ­ed in the Mod­er­na and FDA pre­sen­ta­tions has sev­er­al seri­ous lim­i­ta­tions, accord­ing to the six advis­ers who spoke to CNN.

    First, the num­bers were very small: The study ana­lyzed only hun­dreds of patients, and only 16 became infect­ed. None of them end­ed up in the emer­gency room or were hos­pi­tal­ized.

    ...

    Sec­ond, par­tic­i­pants were not ran­dom­ly assigned to receive either the orig­i­nal or new vac­cine, and the study was not dou­ble-blind, mean­ing the par­tic­i­pants and the researchers knew who was receiv­ing which shot. Lack of ran­dom­iza­tion and blind­ing can bias study results.

    Third, the pri­ma­ry pur­pose of the study was not to study infec­tion rates but to do immuno­genic­i­ty analy­ses, tak­ing blood from par­tic­i­pants and exam­in­ing their anti­body respons­es to the vac­cine.

    ...

    “The pri­ma­ry objec­tive of the study was to assess the safe­ty and immuno­genic­i­ty of the biva­lent vac­cine. The study was not ran­dom­ized and did not con­trol for infec­tion risk between arms, mak­ing com­par­i­son of a rel­a­tive­ly small num­ber of cas­es prob­lem­at­ic,” he wrote.

    Near­ly $5 bil­lion for updat­ed boost­ers

    On August 31, about two months after the FDA advis­ers’ meet­ing, the agency autho­rized the Mod­er­na biva­lent vac­cines. The Mod­er­na infec­tion data was includ­ed in the agency’s writ­ten deci­sion, but it wasn’t post­ed online until Sep­tem­ber 13, accord­ing to Fel­ber­baum, the FDA spokesman.

    On Sep­tem­ber 1, the CDC advis­ers – 14 vot­ing mem­bers – met to con­sid­er whether to rec­om­mend the biva­lent boost­ers for Amer­i­cans to get in the fall. Sev­er­al CDC sci­en­tists pre­sent­ed data at that meet­ing but did not include the infec­tion data.

    Nord­lund, the CDC spokes­woman, said in her email that the “CDC was aware” of the data that would lat­er be pub­lished in The New Eng­land Jour­nal of Med­i­cine but that assess­ing infec­tions was an “explorato­ry objec­tive of the study,” which was “not designed to assess vac­cine effec­tive­ness.” She added that in assess­ing infec­tions, “researchers used dif­fer­ent dura­tions and points in time among a very small group of peo­ple,” and because of the lim­i­ta­tions of the data, it was not fea­tured at the meet­ing.

    “CDC vac­cine rec­om­men­da­tions are made fol­low­ing an eval­u­a­tion and pre­sen­ta­tion of high-qual­i­ty vac­cine effi­ca­cy or immuno­bridg­ing data,” Nord­lund wrote.

    Dr. William Schaffn­er, a non-vot­ing mem­ber of the CDC’s advi­so­ry com­mit­tee, called Nordlund’s argu­ment “very weak.”

    “The data are lim­it­ed, but they are infor­ma­tive, and I think one would have antic­i­pat­ed that a com­plete pre­sen­ta­tion would have includ­ed them,” said Schaffn­er, an infec­tious dis­ease spe­cial­ist at Van­der­bilt Uni­ver­si­ty Med­ical Cen­ter.

    Dr. Jacque­line Miller, a senior vice pres­i­dent at Mod­er­na, pre­sent­ed to the advis­ers. Like her col­league Hoge, the com­pa­ny pres­i­dent, she showed mate­r­i­al sug­gest­ing that the biva­lent vac­cine was supe­ri­or and did not show slides detail­ing the sta­tis­tics about the infec­tion rates, accord­ing to a copy of the slides she pre­sent­ed.

    Sev­er­al hours into the meet­ing, one of the CDC advis­ers, Dr. Sybil Cineas, an asso­ciate pro­fes­sor of med­i­cine at the War­ren Alpert Med­ical School of Brown Uni­ver­si­ty, asked Miller about cas­es of Covid-19 among study sub­jects who received the orig­i­nal vac­cine ver­sus the updat­ed biva­lent boost­er.

    Miller said that among sub­jects with no evi­dence of pri­or infec­tion, as well as those with evi­dence of pri­or infec­tion, the dis­ease inci­dence rates were 2.4% for the group who received the orig­i­nal vac­cine and 2.5% for those who got the biva­lent boost­er.

    That data would be pub­lished two weeks lat­er in The New Eng­land Jour­nal of Med­i­cine.

    When she answered Cineas’ ques­tion, Miller did not men­tion oth­er aspects of the infec­tion data in the pub­lished study. That data indi­cat­ed that among hun­dreds of par­tic­i­pants with no pre­vi­ous Covid-19 infec­tions, infec­tion occurred in 1.9% of those who’d received the old vac­cine and in 3.2% of those who’d received the new biva­lent vac­cine. She also did not men­tion break­downs of whether par­tic­i­pants were sick with Covid or had asymp­to­matic ill­ness­es. The study, like the preprint, did not men­tion whether any of these find­ings were sta­tis­ti­cal­ly sig­nif­i­cant.

    At the end of the meet­ing, the CDC advis­ers vot­ed 13–1 in favor of rec­om­mend­ing the biva­lent boost­er, with Sanchez, a pro­fes­sor of pedi­atrics at the Ohio State Uni­ver­si­ty Col­lege of Med­i­cine, vot­ing in oppo­si­tion. CDC Direc­tor Dr. Rochelle Walen­sky signed off on the rec­om­men­da­tion lat­er that day, and the vac­cines were made avail­able to the pub­lic. Cur­rent­ly, they are the only boost­er avail­able once some­one has had their pri­ma­ry series of a Covid-19 vac­cine.

    More than six months after the FDA advis­ers met, Mod­er­na still has not released data from a ran­dom­ized Phase 3 tri­al com­par­ing infec­tions in par­tic­i­pants who received the new boost­er with those who received the old shot. The com­pa­ny expects to release such results “short­ly” with about 3,000 par­tic­i­pants, accord­ing to Rid­ley.

    Pfiz­er does not “cur­rent­ly have data on inci­dence of infec­tion post biva­lent boost­er. How­ev­er, we con­tin­ue to mon­i­tor real-world data and col­lect data from our own stud­ies,” accord­ing to a state­ment from Jer­i­ca Pitts, senior direc­tor of glob­al media rela­tions.

    Togeth­er, the new updat­ed boost­ers from Pfiz­er and Mod­er­na cost tax­pay­ers near­ly $5 bil­lion. To put that in per­spec­tive, that’s about the size of the annu­al bud­get for the state of Delaware.

    For­mer FDA sci­en­tist: No excuse for exclud­ing infec­tion data

    A for­mer FDA sci­en­tist who helped run the agency’s vac­cine divi­sion told CNN that if he were still at the agency, he would have advo­cat­ed for shar­ing the infec­tion infor­ma­tion with the advis­ers, even if it was made avail­able only a short time before the meet­ing.

    “I don’t think there’s any excuse for exclud­ing it,” even with its imper­fec­tions, said Dr. Philip Krause, who served as deputy direc­tor of the FDA’s Office of Vac­cine Research and Review until he resigned in Octo­ber 2021.

    “The company’s fail­ure to present this infor­ma­tion at the [FDA advis­ers meet­ing] and the omis­sion of dis­cus­sion about the data at that meet­ing rais­es ques­tions about the abil­i­ty of the process to pro­vide a full and trans­par­ent review of the data,” he added.

    Krause said his main con­cern was pre­serv­ing – or regain­ing – the pub­lic trust in the FDA.

    “That’s the crit­i­cal thing,” he said. “The FDA’s objec­tive review of the data is what is pro­vid­ing the great, great val­ue to the Amer­i­can peo­ple, because this way they know that some­body who doesn’t have a stake in the out­come has looked at the deep­est pos­si­ble lev­el at these data.”

    FDA and CDC vac­cine advis­ers echoed Krause’s con­cerns about trans­paren­cy.

    “I think that as much data that’s avail­able should be made pub­lic and avail­able for dis­cus­sion by advi­so­ry groups so that the pub­lic can see, yes, the avail­able sci­ence has been eval­u­at­ed as best as [pos­si­ble] at that par­tic­u­lar time,” said Bern­stein, the mem­ber of the FDA advi­so­ry com­mit­tee.

    Bern­stein added that he was dis­ap­point­ed that the data had not been pre­sent­ed to him and the oth­er advis­ers.

    Offit, the mem­ber from the Uni­ver­si­ty of Penn­syl­va­nia, said he was angry.

    “I was angry to find out that there was data that was rel­e­vant to our deci­sion that I didn’t get to see. Angry because they should trust us to make the deci­sion based on all the data. These agen­cies, whether it’s the FDA or CDC, can’t make that deci­sion for us. That’s the point of hav­ing an inde­pen­dent advi­so­ry com­mit­tee,” he said.

    ‘It shook my faith’

    About a month after the CDC advis­ers met, stud­ies were released from researchers at Har­vard and Colum­bia sug­gest­ing that the new vac­cines didn’t work any bet­ter than the orig­i­nal.

    Those stud­ies, which were very small and only in preprint and not in a med­ical jour­nal, mea­sured immune respons­es after peo­ple got the biva­lent vac­cine com­pared with the orig­i­nal ver­sion of the vac­cine.

    “We essen­tial­ly see no dif­fer­ence” between the old boost­ers and the new about a month after the shot, said Dr. David Ho, a pro­fes­sor of micro­bi­ol­o­gy and immunol­o­gy at Colum­bia whose team authored one of the stud­ies.

    Pres­i­dent Joe Biden and oth­er admin­is­tra­tion offi­cials con­tin­ue to empha­size that the updat­ed boost­er is the best way to avoid hos­pi­tal­iza­tion or death from Covid-19. But near­ly four months after its release, only 15.4% of the US pop­u­la­tion age 5 and old­er has opt­ed to get the shot, accord­ing to CDC data.

    On Jan­u­ary 26, the advis­ers are sched­uled to meet again to dis­cuss future Covid-19 vac­ci­na­tion reg­i­mens.

    Offit, the FDA vac­cine advis­er, said the Colum­bia and Har­vard stud­ies con­vinced him even more that the infec­tion data and all the relat­ed caveats should have been giv­en to the advis­ers from the begin­ning.

    “This was not accept­able. I under­stand we’re in the mid­dle of a pan­dem­ic. I under­stand we’re build­ing the plane while it’s still in the air, but you can’t do this,” he said. “It did shake my faith. It shook my faith in how these deci­sions were being made.”

    ——–

    “FDA vac­cine advis­ers ‘dis­ap­point­ed’ and ‘angry’ that ear­ly data about new Covid-19 boost­er shot wasn’t pre­sent­ed for review last year” by Eliz­a­beth Cohen and Nao­mi Thomas; CNN; 01/11/2023

    “At a meet­ing of this FDA advi­so­ry group in June and a meet­ing in Sep­tem­ber of a pan­el that advis­es the US Cen­ters for Dis­ease Con­trol and Pre­ven­tion, the experts were pre­sent­ed with reams of infor­ma­tion indi­cat­ing that the new vac­cine worked bet­ter than the one already on shelves, accord­ing to a review of videos and tran­scripts of those meet­ings and slide pre­sen­ta­tions made by Mod­er­na, CDC and FDA offi­cials.”

    An FDA advi­so­ry group in June and a Sep­tem­ber meet­ing at the CDC and last year, where out­side experts on an inde­pen­dent advi­so­ry pan­el were pre­sent­ed infor­ma­tion indi­ca­tion that at the new biva­lent Mod­er­na mRNA vac­cines real­ly did per­form bet­ter than the orig­i­nal for­mu­la­tion. Mod­er­na, the FDA, and CDC all played a role in pre­sent­ing this infor­ma­tion to the inde­pen­dent experts. Infor­ma­tion that sys­tem­at­i­cal­ly left out the results from Mod­er­na’s stud­ies show­ing no improve­ment over the orig­i­nal vac­cines in terms of actu­al infec­tions. In fact, the new biva­lent vac­cines per­formed even worse than the orig­i­nal vac­cine in terms of infec­tions. That ear­ly data was avail­able when these meet­ings took place. Some of that ear­ly data was even shared, like the data show­ing high­er anti­body lev­els result­ing from the biva­lent boost­ers. And yet some­how the data show­ing high­er rates of infec­tion was sys­tem­at­i­cal­ly left out of all these pre­sen­ta­tions to the advi­so­ry pan­el. So this was­n’t just Mod­er­na play­ing fast and loose with the avail­able data. The FDA and CDC were play­ing their roles too. It’s the kind of sit­u­a­tion that just screams ‘reg­u­la­to­ry cap­ture’:

    ...
    That data – called immuno­genic­i­ty data – was based on blood work done on study par­tic­i­pants to assess how well each vac­cine elicit­ed anti­bod­ies that fight off the Omi­cron strain of the virus that caus­es Covid-19.

    The data that was not pre­sent­ed to the experts looked at actu­al infec­tions: who caught Covid-19 and who did not.

    It found that 1.9% of the study par­tic­i­pants who received the orig­i­nal boost­er became infect­ed. Among those who got the updat­ed biva­lent vac­cine – the one that sci­en­tists hoped would work bet­ter – a high­er per­cent­age, 3.2%, became infect­ed. Both ver­sions of the shot were found to be safe.

    This infec­tion data was far from com­plete. The num­ber of study sub­jects who became infect­ed was very small, and both the patients and the researchers were aware of who was get­ting the orig­i­nal shot and who was get­ting the new boost­er.

    Despite these imper­fec­tions, the data was includ­ed in a preprint study that was post­ed online in June, again in Sep­tem­ber in an FDA doc­u­ment and then lat­er that month in a top med­ical jour­nal – and advis­ers to the FDA and the CDC said the data should have been shared with them, too.
    ...

    And as we can see, part of the way this cen­sor­ship was car­ried out was via Mod­er­na’s release of the preprint ear­ly data — data show­ing high­er infec­tion rates for the biva­lent boost­ers — just days before the June 28 FDA meet­ing, which appar­ent­ly gave Mod­er­na and the FDA an excuse to with­hold the study on the premise that the three days was­n’t enough time to review it. So what was the CDC’s excuse for leav­ing the data out of its Sep­tem­ber meet­ing with the inde­pen­dent pan­el? We are told that the CDC decid­ed to leave it out, “due to the many lim­i­ta­tions involv­ing this clin­i­cal data, it was not fea­tured.”:

    ...
    The FDA and the CDC con­vene their advi­so­ry board meet­ings and make pre­sen­ta­tions to the advis­ers. At last year’s meet­ings, Mod­er­na exec­u­tives made pre­sen­ta­tions, as well. The advis­ers then make their rec­om­men­da­tions to the agen­cies, and the agen­cies decide whether to autho­rize the shots and rec­om­mend them to the pub­lic.

    Mod­er­na spokesman Christo­pher Rid­ley said in an email to CNN that the com­pa­ny shared the infec­tion data with the FDA and post­ed the study man­u­script before the agency’s pan­el meet­ing in June “in response to requests that we share an update from the ongo­ing study.”

    That study preprint was post­ed online June 25, three days before the FDA advis­ers met.

    Michael Fel­ber­baum, an FDA spokesman, told CNN in an email that “the FDA received the preprint less than a day pri­or to the advi­so­ry com­mit­tee meet­ing,” and “the infor­ma­tion was there­fore not pro­vid­ed in an ade­quate time­frame for it to be includ­ed in the agency’s meet­ing mate­ri­als, and gen­er­al­ly the FDA only dis­cuss­es data at advi­so­ry com­mit­tee meet­ings that the agency has had the oppor­tu­ni­ty to sub­stan­tive­ly review.”

    “Numer­ous stud­ies sup­port the find­ing that the COVID-19 vac­cines remain the best defense against the most dev­as­tat­ing con­se­quences of COVID-19 such as hos­pi­tal­iza­tion and death, and that the updat­ed vac­cines may help pro­vide bet­ter pro­tec­tion against the cur­rent­ly cir­cu­lat­ing vari­ants,” Fel­ber­baum wrote.

    He added that “through­out the pan­dem­ic, the FDA has remained as trans­par­ent as pos­si­ble regard­ing its process­es and deci­sion-mak­ing regard­ing the COVID-19 vac­cines” and that Mod­er­na could have cho­sen to present the data at the FDA advi­so­ry com­mit­tee meet­ing.

    Kris­ten Nord­lund, a CDC spokes­woman, said that “due to the many lim­i­ta­tions involv­ing this clin­i­cal data, it was not fea­tured” in the CDC’s advi­so­ry com­mit­tee dis­cus­sion.
    ...

    And yet, despite the CDC and FDA mak­ing the deci­sion to leave Mod­er­na’s preprint­ed study out of its pan­el review dur­ing that day-long June 28 meet­ing, we learn that Mod­er­na’s pres­i­dent nonethe­less made fre­quent ref­er­ences to the preprint­ed study’s results. At least the parts about high­er anti­body lev­els that he want­ed to share. But no men­tion of the high­er infec­tion rates. That’s the sto­ry here: the FDA, CDC, and Mod­er­na effec­tive­ly teamed up to bam­boo­zle this pan­el of inde­pen­dent experts:

    ...
    Infec­tion data not includ­ed in pre­sen­ta­tions by FDA and Mod­er­na

    Last sum­mer, as the FDA’s and CDC’s out­side advis­ers con­sid­ered the updat­ed boost­ers, the stakes were high. They knew that in just a mat­ter of months, win­ter would be approach­ing, and Covid rates could spike. They also knew the orig­i­nal vac­cine was get­ting less effec­tive with each new vari­ant and that the addi­tion of the Omi­cron strain in the updat­ed boost­er might help bat­tle the virus.

    The FDA advis­ers – 21 vot­ing mem­bers, includ­ing infec­tious dis­ease experts and vac­ci­nol­o­gists from Stan­ford, the Uni­ver­si­ty of Penn­syl­va­nia and Har­vard – met for a full day on June 28.

    Dr. Stephen Hoge, the pres­i­dent of Mod­er­na, made a pre­sen­ta­tion to the advis­ers and fre­quent­ly referred to infor­ma­tion from the preprint study that had been post­ed three days before. The study was fund­ed by Mod­er­na and led by com­pa­ny sci­en­tists, and it had not been sub­ject­ed to peer review or pub­lished in a med­ical jour­nal.

    The data Hoge shared with the advis­ers demon­strat­ed that blood tests on about 800 study par­tic­i­pants indi­cat­ed that the new biva­lent boost­er was “supe­ri­or” at increas­ing anti­bod­ies to the Omi­cron vari­ant com­pared with the orig­i­nal vac­cine.

    Hoge did not men­tion anoth­er part of the study that cast a less-pos­i­tive light on the updat­ed shot.

    In that part, the researchers gave some par­tic­i­pants the exist­ing vac­cine and oth­er par­tic­i­pants the updat­ed boost­er, and then they kept track of who became infect­ed with Covid-19.

    Among the hun­dreds of par­tic­i­pants who received the orig­i­nal vac­cine and showed no evi­dence of a pri­or Covid-19 infec­tion, over the peri­od of the small study, 1.9% became infect­ed. Among the hun­dreds who received the new biva­lent vac­cine, a high­er per­cent­age, 3.2%, became infect­ed. The preprint did not indi­cate whether these find­ings were sta­tis­ti­cal­ly sig­nif­i­cant.

    A 22-page FDA brief­ing doc­u­ment giv­en to the advis­ers did not men­tion this infec­tion data.
    ...

    And note how even the experts serv­ing on this advi­so­ry pan­el who still approve of the biva­lent vac­cine are angered over this sto­ry. As they should be. These are the experts tasked with sift­ing through all the avail­able data and mak­ing an inde­pen­dent rec­om­men­da­tion. The check and bal­ances of this sys­tem were cor­rupt­ed:

    ...
    “It’s not a group of chil­dren. We under­stand how to inter­pret these results,” said Dr. Eric Rubin, a mem­ber of the FDA vac­cine advi­so­ry com­mit­tee.

    The six FDA and CDC advis­ers inter­viewed by CNN said that this infec­tion data wouldn’t have changed how they vot­ed, because the data had such lim­i­ta­tions, but it still should have been pre­sent­ed to them.

    “There should always be full trans­paren­cy,” said Dr. Arnold Mon­to, a pro­fes­sor of epi­demi­ol­o­gy at the Uni­ver­si­ty of Michi­gan School of Pub­lic Health and act­ing chair of the FDA advis­ers’ group. “These data should not be dis­missed. They are ear­ly, but they indi­cate that we need to look at them and see what their val­ue is.”

    Dr. Pablo Sanchez, a mem­ber of the CDC’s pan­el, called the Advi­so­ry Com­mit­tee on Immu­niza­tion Prac­tices, said that if the data “was looked at as part of the study, it should have been pre­sent­ed to the advis­ers pri­or to their deci­sion.”
    ...

    Also note the oth­er games at work with the release of Mod­er­na’s find­ings: the FDA autho­rized the use of the biva­lent vac­cines on August 31. A deci­sion the FDA did­n’t post online the data that it based that deci­sion on until Sep­tem­ber 13, which includ­ed the Mod­er­na infec­tion data. But it was Sep­tem­ber 1 when the CDC held its own “Advi­so­ry Com­mit­tee on Immu­niza­tion Prac­tices” and that infec­tion data was once again with­held from pan­el. So what’s the CDC’s expla­na­tion? Well, the agency acknowl­edges that it was “aware” that the infec­tion data would be lat­er pub­lished in the New Eng­land Jour­nal of Med­i­cine and that the focus of the meet­ing was on vac­cine safe­ty, not vac­cine effec­tive­ness. It was, as Dr. William Schaffn­er put it, a “very weak” defense:

    ...
    On August 31, about two months after the FDA advis­ers’ meet­ing, the agency autho­rized the Mod­er­na biva­lent vac­cines. The Mod­er­na infec­tion data was includ­ed in the agency’s writ­ten deci­sion, but it wasn’t post­ed online until Sep­tem­ber 13, accord­ing to Fel­ber­baum, the FDA spokesman.

    On Sep­tem­ber 1, the CDC advis­ers – 14 vot­ing mem­bers – met to con­sid­er whether to rec­om­mend the biva­lent boost­ers for Amer­i­cans to get in the fall. Sev­er­al CDC sci­en­tists pre­sent­ed data at that meet­ing but did not include the infec­tion data.

    Nord­lund, the CDC spokes­woman, said in her email that the “CDC was aware” of the data that would lat­er be pub­lished in The New Eng­land Jour­nal of Med­i­cine but that assess­ing infec­tions was an “explorato­ry objec­tive of the study,” which was “not designed to assess vac­cine effec­tive­ness.” She added that in assess­ing infec­tions, “researchers used dif­fer­ent dura­tions and points in time among a very small group of peo­ple,” and because of the lim­i­ta­tions of the data, it was not fea­tured at the meet­ing.

    “CDC vac­cine rec­om­men­da­tions are made fol­low­ing an eval­u­a­tion and pre­sen­ta­tion of high-qual­i­ty vac­cine effi­ca­cy or immuno­bridg­ing data,” Nord­lund wrote.

    Dr. William Schaffn­er, a non-vot­ing mem­ber of the CDC’s advi­so­ry com­mit­tee, called Nordlund’s argu­ment “very weak.”

    “The data are lim­it­ed, but they are infor­ma­tive, and I think one would have antic­i­pat­ed that a com­plete pre­sen­ta­tion would have includ­ed them,” said Schaffn­er, an infec­tious dis­ease spe­cial­ist at Van­der­bilt Uni­ver­si­ty Med­ical Cen­ter.
    ...

    And at that Sep­tem­ber 1 CDC meet­ing, we again find some­one from Mod­er­na pro­mot­ing the results of the com­pa­ny’s preprint­ed study but still leav­ing out the infec­tion data from that same study. There’s just no deny­ing this was a gross coverup:

    ...
    Dr. Jacque­line Miller, a senior vice pres­i­dent at Mod­er­na, pre­sent­ed to the advis­ers. Like her col­league Hoge, the com­pa­ny pres­i­dent, she showed mate­r­i­al sug­gest­ing that the biva­lent vac­cine was supe­ri­or and did not show slides detail­ing the sta­tis­tics about the infec­tion rates, accord­ing to a copy of the slides she pre­sent­ed.

    Sev­er­al hours into the meet­ing, one of the CDC advis­ers, Dr. Sybil Cineas, an asso­ciate pro­fes­sor of med­i­cine at the War­ren Alpert Med­ical School of Brown Uni­ver­si­ty, asked Miller about cas­es of Covid-19 among study sub­jects who received the orig­i­nal vac­cine ver­sus the updat­ed biva­lent boost­er.

    Miller said that among sub­jects with no evi­dence of pri­or infec­tion, as well as those with evi­dence of pri­or infec­tion, the dis­ease inci­dence rates were 2.4% for the group who received the orig­i­nal vac­cine and 2.5% for those who got the biva­lent boost­er.

    That data would be pub­lished two weeks lat­er in The New Eng­land Jour­nal of Med­i­cine.

    When she answered Cineas’ ques­tion, Miller did not men­tion oth­er aspects of the infec­tion data in the pub­lished study. That data indi­cat­ed that among hun­dreds of par­tic­i­pants with no pre­vi­ous Covid-19 infec­tions, infec­tion occurred in 1.9% of those who’d received the old vac­cine and in 3.2% of those who’d received the new biva­lent vac­cine. She also did not men­tion break­downs of whether par­tic­i­pants were sick with Covid or had asymp­to­matic ill­ness­es. The study, like the preprint, did not men­tion whether any of these find­ings were sta­tis­ti­cal­ly sig­nif­i­cant.
    ...

    Even Dr. Philip Krause — who served as deputy direc­tor of the FDA’s Office of Vac­cine Research and Review until he resigned in Octo­ber 2021 — is call­ing the FDA’s deci­sion a fail­ure that rais­es ques­tions about the abil­i­ty of the process to oper­ate trans­par­ent­ly:

    ...
    A for­mer FDA sci­en­tist who helped run the agency’s vac­cine divi­sion told CNN that if he were still at the agency, he would have advo­cat­ed for shar­ing the infec­tion infor­ma­tion with the advis­ers, even if it was made avail­able only a short time before the meet­ing.

    “I don’t think there’s any excuse for exclud­ing it,” even with its imper­fec­tions, said Dr. Philip Krause, who served as deputy direc­tor of the FDA’s Office of Vac­cine Research and Review until he resigned in Octo­ber 2021.

    The company’s fail­ure to present this infor­ma­tion at the [FDA advis­ers meet­ing] and the omis­sion of dis­cus­sion about the data at that meet­ing rais­es ques­tions about the abil­i­ty of the process to pro­vide a full and trans­par­ent review of the data,” he added.
    ...

    And as Dr. Paul Offit — one of two mem­ber of the 19-mem­ber FDA advi­so­ry pan­el to vote against approv­ing the biva­lent vac­cine — reminds us, the whole pur­pose of giv­ing all the rel­e­vant data to an inde­pen­dent advi­so­ry pan­el is to have an out­side group of experts weigh­ing in on these deci­sions. In oth­er words, they cor­rupt­ed the integri­ty of the process:

    ...
    FDA and CDC vac­cine advis­ers echoed Krause’s con­cerns about trans­paren­cy.

    “I think that as much data that’s avail­able should be made pub­lic and avail­able for dis­cus­sion by advi­so­ry groups so that the pub­lic can see, yes, the avail­able sci­ence has been eval­u­at­ed as best as [pos­si­ble] at that par­tic­u­lar time,” said Bern­stein, the mem­ber of the FDA advi­so­ry com­mit­tee.

    Bern­stein added that he was dis­ap­point­ed that the data had not been pre­sent­ed to him and the oth­er advis­ers.

    Offit, the mem­ber from the Uni­ver­si­ty of Penn­syl­va­nia, said he was angry.

    “I was angry to find out that there was data that was rel­e­vant to our deci­sion that I didn’t get to see. Angry because they should trust us to make the deci­sion based on all the data. These agen­cies, whether it’s the FDA or CDC, can’t make that deci­sion for us. That’s the point of hav­ing an inde­pen­dent advi­so­ry com­mit­tee,” he said.
    ...

    And then we get to the inde­pen­dent study that came out in Octo­ber that found basi­cal­ly no dif­fer­ence between the orig­i­nal mRNA Mod­er­na vac­cine and the biva­lent boost­er. As Dr. Offit describes, it’s the kind of expe­ri­ence that shook his faith in the whole process:

    ...
    About a month after the CDC advis­ers met, stud­ies were released from researchers at Har­vard and Colum­bia sug­gest­ing that the new vac­cines didn’t work any bet­ter than the orig­i­nal.

    Those stud­ies, which were very small and only in preprint and not in a med­ical jour­nal, mea­sured immune respons­es after peo­ple got the biva­lent vac­cine com­pared with the orig­i­nal ver­sion of the vac­cine.

    “We essen­tial­ly see no dif­fer­ence” between the old boost­ers and the new about a month after the shot, said Dr. David Ho, a pro­fes­sor of micro­bi­ol­o­gy and immunol­o­gy at Colum­bia whose team authored one of the stud­ies.

    ...

    Offit, the FDA vac­cine advis­er, said the Colum­bia and Har­vard stud­ies con­vinced him even more that the infec­tion data and all the relat­ed caveats should have been giv­en to the advis­ers from the begin­ning.

    “This was not accept­able. I under­stand we’re in the mid­dle of a pan­dem­ic. I under­stand we’re build­ing the plane while it’s still in the air, but you can’t do this,” he said. “It did shake my faith. It shook my faith in how these deci­sions were being made.”
    ...

    So are bet­ter-pow­ered stud­ies on the way that can at least cre­ate some clar­i­ty on these ques­tions and vac­cine effec­tive­ness? Well, Mod­er­na still has­n’t released data from a ran­dom­ized Phase 3 tri­al com­par­ing infec­tions in par­tic­i­pants who received the new boost­er with those who received the old shot. But we can expect those results “short­ly”. And Pfiz­er just isn’t ask­ing the ques­tion it seems. Although recall how the com­pa­ny released a study back in Octo­ber tout­ing how its boost­er lift­ed anti­body lev­els while neglect­ing to pro­vide data on shot’s effi­ca­cy. In oth­er words, don’t held your breath:

    ...
    More than six months after the FDA advis­ers met, Mod­er­na still has not released data from a ran­dom­ized Phase 3 tri­al com­par­ing infec­tions in par­tic­i­pants who received the new boost­er with those who received the old shot. The com­pa­ny expects to release such results “short­ly” with about 3,000 par­tic­i­pants, accord­ing to Rid­ley.

    Pfiz­er does not “cur­rent­ly have data on inci­dence of infec­tion post biva­lent boost­er. How­ev­er, we con­tin­ue to mon­i­tor real-world data and col­lect data from our own stud­ies,” accord­ing to a state­ment from Jer­i­ca Pitts, senior direc­tor of glob­al media rela­tions.
    ...

    Final­ly, let’s just keep in mind one of the oth­er dis­turb­ing details in this sto­ry: these mRNA boost­ers are cur­rent­ly the ONLY boost­ers avail­able in the US:

    ...
    At the end of the meet­ing, the CDC advis­ers vot­ed 13–1 in favor of rec­om­mend­ing the biva­lent boost­er, with Sanchez, a pro­fes­sor of pedi­atrics at the Ohio State Uni­ver­si­ty Col­lege of Med­i­cine, vot­ing in oppo­si­tion. CDC Direc­tor Dr. Rochelle Walen­sky signed off on the rec­om­men­da­tion lat­er that day, and the vac­cines were made avail­able to the pub­lic. Cur­rent­ly, they are the only boost­er avail­able once some­one has had their pri­ma­ry series of a Covid-19 vac­cine.
    ...

    Want a boost­er? Well, you can choose between the Mod­er­na mRNA boost­er that was appar­ent­ly cod­dled through the whole approval process. Or the Pfiz­er boost­er, which basi­cal­ly got to pig­gy-back off of Mod­er­na’s favored sta­tus. Despite the array of COVID vac­cines that have been devel­oped in recent years, those are the only two read­i­ly avail­able boost­er options today in the US. Fun­ny how that hap­pened.

    Posted by Pterrafractyl | January 24, 2023, 5:49 pm
  6. @Pterrafractyl–

    Bril­liant, impor­tant, inci­sive!

    Great, great work!

    Best,

    Dave

    Posted by Dave Emory | January 24, 2023, 6:08 pm
  7. The per­ils of reg­u­la­to­ry cap­ture is noth­ing new for the US. Per­ils that have become all the more acute in the era of COVID and the num­ber of ques­tions that have already arisen over the reg­u­la­to­ry treat­ment of the var­i­ous COVID vac­cines. Reg­u­la­to­ry treat­ment that, as we’ve seen, seems to be heav­i­ly weight­ed towards push­ing as many peo­ple into tak­ing the mRNA COVID vac­cines as pos­si­ble. Favoritism that man­i­fest­ed as both approval the mRNA vac­cines despite shaky safe­ty evi­dence while simul­ta­ne­ous­ly block­ing or lim­it­ing the approval of non-mRNA alter­na­tives for high­ly ques­tion­able rea­sons. For exam­ple, there was that dis­turb­ing report from back in Jan­u­ary about how the FDA, CDC, and Mod­er­na all seemed to col­lude in with­hold­ing from an inde­pen­dent advi­so­ry pan­el unflat­ter­ing data about the effi­ca­cy of the new biva­lent COVID vac­cines. And then there was the FDA deci­sion back in May of 2022 that effec­tive­ly killed the J&J vac­cine as as pub­lic option after warn­ing the pub­lic away from the J&J vac­cine based on some very rare side effects, despite evi­dence that the J&J vac­cine pro­vid­ed bet­ter long-term defens­es against COVID.

    But the J&J vac­cine was just one of the non-mRNA alter­na­tives made avail­able in the US. US-based Novavax already released its own pro­tein-based COVID vac­cine. And yet that vac­cine was only giv­en emer­gency autho­riza­tion approval for pri­ma­ry shots in July of 2022 and emer­gency autho­riza­tion for a first boost­er shot in Octo­ber of 2022. But ONLY the first boost­er shot. There remains NO non-mRNA vac­cines avail­able for addi­tion­al boost­er shots in the US to this day. It’s a sit­u­a­tion that just screams “Reg­u­la­to­ry Cap­ture!”

    That ongo­ing reg­u­la­to­ry cap­ture is a big part of the con­text of the fol­low­ing arti­cles. And not just the reg­u­la­to­ry cap­ture of the US gov­ern­ment. It turns out the EU is expe­ri­enc­ing a COVID reg­u­la­to­ry-cap­ture scan­dal of its own. A scan­dal cen­tered around none oth­er then EU Com­mis­sions Pres­i­dent Ursu­la von der Leyen. Yep, it turns out that von der Leyen and Pfiz­er CEO Albert Bourla were exchang­ing text mes­sages in the lead up to a mas­sive multi­bil­lion euro con­tract to pur­chase mil­lions of mRNA COVID vac­cines. Text mes­sage that the EU par­lia­ment has a keen inter­est in review­ing. But nei­ther von der Leyen nor Bourla has any inter­est in hand­ing them over.

    In response, the par­lia­men­tary COVID-19 com­mit­tee issues for­mal invites to both von der Leyen and Bourla back in Jan­u­ary to pub­licly answer ques­tions about these mes­sages and the con­tracts. The prob­lem is these are non-legal­ly-bind­ing invites and both refused. So are the con­tents of those text mes­sages going to remain a secret for­ev­er? Sort of. We got an update on this par­lia­men­tary stand­off between von der Leyen and the par­lia­ment a cou­ple of weeks ago: first, the New York Times launched a law­suit against the EU Com­mis­sion to force the release of the texts. Then, a few days lat­er, we learned that the Con­fer­ence of Presidents—the EU Parliament’s polit­i­cal lead­ers— decid­ed to sim­ply hold ‘an exchange of views’ with Ursu­la von der Leyen in a pri­vate ses­sion. It’s not a great look.

    So while ques­tions about the reg­u­la­to­ry cap­ture of the US vac­cine mar­kets don’t appear to be going away any time soon, we can’t for­get that the EU isn’t immune to reg­u­la­to­ry cap­ture of its own. But there’s anoth­er angle here to keep in mind: Pfiz­er pre­sum­ably isn’t the only enti­ty that was involved with lob­by­ing von der Leyen in the lead up to that mas­sive con­tract. Pfiz­er’s part­ner in the vac­cine, after all, is Ger­man biotech start­up BioN­Tech. And as we’ve seen, while BioN­Tech is typ­i­cal­ly described as a small Ger­man start­up firm, its insti­tu­tion­al investors include fig­ures like the twin broth­ers Thomas and Andreas Stru­eng­mann, who have deep ties to the Ger­man biotech indus­try.

    What kind of lob­by­ing role is BioN­Tech’s insti­tu­tion­al investor com­mu­ni­ty play­ing in the lob­by­ing of gov­ern­ments over COVID vac­cine poli­cies? It’s a ques­tion that’s been asked quite a bit when it comes to Mod­er­na and Pfiz­er, not so much BioN­Tech. And yet, it’s hard to imag­ine Pfiz­er was the only enti­ty swap­ping texts with von der Leyen about a mas­sive EU vac­cine pur­chase. Why would­n’t BioN­Tech have been involved with lob­by­ing the EU Com­mis­sion Pres­i­dent who hap­pens to hale from Ger­many? Espe­cial­ly when she is noto­ri­ous being a cor­rupt cor­po­rate shill.

    Oh, and as the fol­low­ing arti­cle warns, it turns out Novavax is at risk of going bank­rupt this year, thanks in part to the US gov­ern­men­t’s refusal to grant it more than just emer­gency autho­riza­tion sta­tus. So the the only remain­ing com­pa­ny mak­ing a non-mRNA vac­cine read­i­ly avail­able in the mar­ket in the US is prob­a­bly going out of busi­ness. Great news for Mod­er­na and Pfizer/BioNTech. Even bet­ter news dur­ing the next pan­dem­ic. Also keep in mind that, while the Novavax vac­cine was already approved by the Euro­pean Union, Cana­da, South Korea, Aus­tralia, New Zealand and Indone­sia as for May of 2022, months before US reg­u­la­tors gave their ini­tial emer­gency approval, Novavax won’t be pro­vid­ed too many more vac­cines to the EU after it goes out of busi­ness either.

    It’s just the lat­est exam­ple of how the reg­u­la­to­ry cap­ture of the vac­cine mar­kets isn’t just a lin­ger­ing prob­lem but a grow­ing one. And not just in the US, appar­ent­ly.

    Ok, first, here’s a look at the warn­ing just issued by Novavax a few days ago. A warn­ing the “sig­nif­i­cant uncer­tain­ty” fac­ing the com­pa­ny. Sig­nif­i­cant uncer­tain­ty over whether or not the com­pa­ny will even sur­vive the year:

    Bar­ron’s

    Novavax Says There Is ‘Sub­stan­tial Doubt’ Around Its Abil­i­ty to Con­tin­ue Oper­at­ing This Year

    By Josh Nathan-Kazis
    Feb. 28, 2023 4:02 pm ET

    Covid-19 vac­cine man­u­fac­tur­er Novavax said Tues­day that there is “sub­stan­tial doubt” about its abil­i­ty to con­tin­ue oper­at­ing through this year.

    In a quar­ter­ly earn­ings report issued after the mar­ket closed, the com­pa­ny said that it expects to have enough cash to fund its oper­a­tions through the year, but that expec­ta­tion is “sub­ject to sig­nif­i­cant uncer­tain­ty” relat­ed to 2023 rev­enues, among oth­er fac­tors.

    “Giv­en these uncer­tain­ties, sub­stan­tial doubt exists regard­ing our abil­i­ty to con­tin­ue as a going con­cern through one year from the date that these finan­cial state­ments are issued,” Novavax (tick­er: NVAX) said in its state­ment.

    Novavax report­ed a net loss of $658 mil­lion in 2022. Rev­enues for 2022 were $2 bil­lion, while expens­es were $2.6 bil­lion. The com­pa­ny had $1.3 bil­lion in cash and cash equiv­a­lents at the end of 2022.

    Those results are worse than the full-year guid­ance Novavax laid out in ear­ly 2022. At the time, the com­pa­ny said it expect­ed 2022 rev­enues of between $4 bil­lion and $5 bil­lion, though it ratch­eted those expec­ta­tions down over the course of the year.

    While Novavax sold 3.2 mil­lion dos­es of its Covid-19 vac­cine to the U.S. gov­ern­ment last July, and anoth­er 1.5 mil­lion dos­es in Jan­u­ary, those U.S. con­tracts will like­ly dry up as the coun­try switch­es to a com­mer­cial mar­ket for the Covid-19 vac­cines.

    The move to a com­mer­cial mar­ket will force Novavax to com­pete direct­ly against the far-bet­ter-resourced Pfiz­er (PFE) and Mod­er­na (MRNA), cast­ing sig­nif­i­cant ques­tions over its 2023 rev­enues. Pfiz­er and Mod­er­na are both fore­cast­ing big dips in their 2023 Covid-19 vac­cine rev­enues; unlike those com­pa­nies, Novavax has nei­ther a mas­sive war chest nor a broad port­fo­lio of oth­er drugs to fall back on.

    Novavax shares were down 10% so far this year as of 2:30 p.m. on Tues­day, and 89% over the past 12 months.

    ...

    Despite promis­ing clin­i­cal data, Novavax has strug­gled to bring its Covid-19 vac­cine to mar­ket, and it sub­stan­tial­ly lags behind its com­peti­tors. While the Mod­er­na and Pfiz­er Covid-19 vac­cines both have full approval from the Food and Drug Admin­is­tra­tion, Novavax’s Covid-19 vac­cine remains avail­able only under an emer­gency use autho­riza­tion. What’s more, it is only autho­rized as a boost­er for peo­ple who can­not or won’t take an mRNA-based vac­cine.

    Only 80,000 dos­es of the Novavax vac­cine have been admin­is­tered in the U.S., com­pared with hun­dreds of mil­lions of dos­es of Mod­er­na and Pfiz­er, accord­ing to the Cen­ters for Dis­ease Con­trol and Pre­ven­tion.

    Barron’s wrote in Jan­u­ary that Novavax has an oppor­tu­ni­ty to under­cut Mod­er­na and Pfiz­er by offer­ing its vac­cine at sharply low­er prices than the mRNA-based vac­cine man­u­fac­tur­ers have dis­cussed.

    “The big guys are kind of set­ting the price points at this point,” John Trizzi­no, Novavax’s chief com­mer­cial offi­cer, told Barron’s at the time. “We’re not going to be yet dis­clos­ing what our pric­ing strat­e­gy is. It’s a lever we will use to our advan­tage based on a vari­ety of oth­er fac­tors.”

    That strat­e­gy, how­ev­er, is con­tin­gent on the com­pa­ny stay­ing in busi­ness. That’s no longer a giv­en.

    ————

    “Novavax Says There Is ‘Sub­stan­tial Doubt’ Around Its Abil­i­ty to Con­tin­ue Oper­at­ing This Year” By Josh Nathan-Kazis; Bar­ron’s; 02/28/2023

    “In a quar­ter­ly earn­ings report issued after the mar­ket closed, the com­pa­ny said that it expects to have enough cash to fund its oper­a­tions through the year, but that expec­ta­tion is “sub­ject to sig­nif­i­cant uncer­tain­ty” relat­ed to 2023 rev­enues, among oth­er fac­tors.

    Will Novavax even be in busi­ness a year from now? Who knows? There’s already “sig­nif­i­cant uncer­tain­ty” about that very ques­tion. The kind of “sig­nif­i­cant uncer­tain­ty” Novavax’s deep-pock­et­ed com­peti­tors like Mod­er­na and Pfiz­er don’t have to wor­ry about. As a result, the US COVID vac­cine mar­ket is poised to go from almost entire­ly dom­i­nat­ed by the mRNA vac­cines to entire­ly dom­i­nat­ed:

    ...
    While Novavax sold 3.2 mil­lion dos­es of its Covid-19 vac­cine to the U.S. gov­ern­ment last July, and anoth­er 1.5 mil­lion dos­es in Jan­u­ary, those U.S. con­tracts will like­ly dry up as the coun­try switch­es to a com­mer­cial mar­ket for the Covid-19 vac­cines.

    The move to a com­mer­cial mar­ket will force Novavax to com­pete direct­ly against the far-bet­ter-resourced Pfiz­er (PFE) and Mod­er­na (MRNA), cast­ing sig­nif­i­cant ques­tions over its 2023 rev­enues. Pfiz­er and Mod­er­na are both fore­cast­ing big dips in their 2023 Covid-19 vac­cine rev­enues; unlike those com­pa­nies, Novavax has nei­ther a mas­sive war chest nor a broad port­fo­lio of oth­er drugs to fall back on.

    Novavax shares were down 10% so far this year as of 2:30 p.m. on Tues­day, and 89% over the past 12 months.
    ...

    And note the under­ly­ing rea­son Novavax’s finan­cial future remains in doubt: US reg­u­la­tors are still refus­ing to give the vac­cine the same ‘full approval’ giv­en to the Mod­er­na and Pfiz­er mRNA vac­cines despite promis­ing clin­i­cal data. And, again, note that it’s not just that the Novavax vac­cine is only autho­rized as a boost­er for peo­ple who refuse the mRNA vac­cines in the US. That only applies to the first boost­er fol­low­ing your pri­ma­ry vac­ci­na­tion. The Novavax vac­cine remains unavail­able for any fol­low up boost­ers in the US. That’s on top of the FDA’s advi­so­ry back in May of 2022 that effec­tive­ly warned the pub­lic away from the J&J vac­cine based on some very rare side effects, despite evi­dence that the J&J vac­cine pro­vid­ed bet­ter long-term defens­es against COVID. The mRNA vac­cines of Mod­er­na and Pfiz­er remain the only boost­ers avail­able in the US after your ini­tial boost­er. That’s part of the con­text of this warn­ing from Novavax: there’s is still only mRNA vac­cines avail­able in the US after you’ve received a boost­er. It’s as if US reg­u­la­tors are intent on ensur­ing there’s no oth­er option and every­one either has to take an mRNA vac­cine or go unvac­ci­nat­ed. Why?

    ...

    Despite promis­ing clin­i­cal data, Novavax has strug­gled to bring its Covid-19 vac­cine to mar­ket, and it sub­stan­tial­ly lags behind its com­peti­tors. While the Mod­er­na and Pfiz­er Covid-19 vac­cines both have full approval from the Food and Drug Admin­is­tra­tion, Novavax’s Covid-19 vac­cine remains avail­able only under an emer­gency use autho­riza­tion. What’s more, it is only autho­rized as a boost­er for peo­ple who can­not or won’t take an mRNA-based vac­cine.

    Only 80,000 dos­es of the Novavax vac­cine have been admin­is­tered in the U.S., com­pared with hun­dreds of mil­lions of dos­es of Mod­er­na and Pfiz­er, accord­ing to the Cen­ters for Dis­ease Con­trol and Pre­ven­tion.
    ...

    And note the oth­er per­verse side effect of Novavax’s finan­cial per­il: Novavax was basi­cal­ly the only mar­ket com­pe­ti­tion Mod­er­na and Pfiz­er faced in the US now that the cost of COVID vac­cines is no longer being cov­ered by the gov­ern­ment:

    ...
    Barron’s wrote in Jan­u­ary that Novavax has an oppor­tu­ni­ty to under­cut Mod­er­na and Pfiz­er by offer­ing its vac­cine at sharply low­er prices than the mRNA-based vac­cine man­u­fac­tur­ers have dis­cussed.

    ...

    That strat­e­gy, how­ev­er, is con­tin­gent on the com­pa­ny stay­ing in busi­ness. That’s no longer a giv­en.
    ...

    It’s like Mod­er­na of Pfiz­er can’t lose in the US. Again, are we look­ing at reg­u­la­to­ry cap­ture? And if so, who are the main play­ers in dri­ving this? Mod­er­na? Pfiz­er? The gov­ern­ment agen­cies that part­nered on devel­op­ing these tech­nolo­gies? A group effort?

    And let’s not for­get one of the oth­er actors in this space: Pfiz­er part­ner BioN­Tech. As we’ve seen, while BioN­Tech is typ­i­cal­ly described as a small Ger­man start­up firm, its insti­tu­tion­al investors include fig­ures like the twin broth­ers Thomas and Andreas Stru­eng­mann, who have deep ties to the Ger­man biotech indus­try. What role might BioN­Tech’s pow­er­ful insti­tu­tion­al investors be play­ing in any sort of shady deal­ings with gov­ern­ments regard­ing COVID vac­cine poli­cies?

    Those are just some of the ques­tions raised in a scan­dal that’s been slow­ly unfold­ing for months now. An EU scan­dal focused on none oth­er than EU Com­mis­sion Pres­i­dent Ursu­la von der Leyen. Specif­i­cal­ly, text mes­sages exchanged between von der Leyen and Pfiz­er CEO Albert Bourla in the lead up to a mas­sive multi­bil­lion euro pur­chase of the Pfizer/BioNTech mRNA vac­cine. Law­mak­ers have a num­ber of ques­tions about that con­tract. But — sur­prise! — it turns out nei­ther von der Leyen nor Bourla has any inter­est in shar­ing those texts. In response, the EU COVID-19 par­lia­men­tary com­mit­tee issued ‘invi­ta­tions’ to von der Leyen and Bourla to pub­licly explain these con­tracts beck in Jan­u­ary. Invi­a­tions that, as we’ll see, are non-bind­ing invi­ta­tions both can refuse. Take a guess was to how that played out:

    Politico.eu

    MEPs want to grill von der Leyen over Pfiz­er vac­cine con­tract

    The Euro­pean Parliament’s COVID-19 com­mit­tee will ask the Euro­pean Com­mis­sion pres­i­dent to appear before the pan­el.

    By Car­lo Mar­tus­cel­li
    Jan­u­ary 11, 2023 5:31 pm CET

    An unwant­ed invite may soon be land­ing in Ursu­la von der Leyen’s mail­box.

    The MEPs lead­ing the Euro­pean Par­lia­men­t’s COVID-19 com­mit­tee have decid­ed to ask the pres­i­dent of the Euro­pean Com­mis­sion to appear pub­licly in front of the pan­el, accord­ing to a state­ment sent exclu­sive­ly to POLITICO by the com­mit­tee’s chair, Bel­gian MEP Kath­leen Van Brempt.

    Law­mak­ers want to ask von der Leyen about her role nego­ti­at­ing a mas­sive, multi­bil­lion euro coro­n­avirus vac­cine con­tract signed at the height of the pan­dem­ic. It was in the run-up to this con­tract that she is report­ed to have exchanged text mes­sages with Pfiz­er’s Chief Exec­u­tive Albert Bourla.

    “The Euro­pean Union has spent a lot of pub­lic resources into the pro­duc­tion and pur­chase of vac­cines dur­ing the pan­dem­ic,” Van Brempt said in the state­ment. “[T]he Par­lia­ment has the right to obtain full trans­paren­cy on the modal­i­ties of these expen­di­tures and the pre­lim­i­nary nego­ti­a­tions lead­ing up to them.”

    So far, the Com­mis­sion Pres­i­dent has dodged ques­tions about what went down in those cru­cial months.

    Nei­ther the EU’s ombuds­man or the Court of Audi­tors have been able to shed a light on the murky deal­ings. The Euro­pean Pub­lic Pros­e­cu­tor’s Office, which is armed with legal pow­ers that the oth­er watch­dog agen­cies lack, has opened an inves­ti­ga­tion into the vac­cine con­tracts, with­out say­ing whether the Com­mis­sion Pres­i­dent is its tar­get.

    The COVID pan­el has been look­ing into the deal — the third and largest con­tract signed with Pfiz­er and its Ger­man part­ner BioN­Tech — and has so far heard from both the Court of Audi­tors and the ombuds­man. But Bourla refused the sum­mons, send­ing an under­ling in his stead.

    Fol­low­ing the Par­lia­men­t’s rules, the invite will be sent to Par­lia­ment Pres­i­dent Rober­ta Met­so­la, who will decide then whether to ask von der Leyen to attend the hear­ing. Met­so­la is a mem­ber of the cen­ter-right Euro­pean Peo­ple’s Par­ty group, the same one that placed the Com­mis­sion Pres­i­dent in her role.

    The invi­ta­tion, if it does arrive, does­n’t have any legal force. Like Bourla, von der Leyen can refuse to appear. But with calls for greater trans­paren­cy grow­ing loud­er as the Qatar­gate cor­rup­tion scan­dal engulfs Brus­sels, she may feel like she can’t say no.

    It’s not just von der Leyen who is in the MEPs’ crosshairs. Van Brempt said in her state­ment that the com­mit­tee would also ask to revoke Pfiz­er’s Euro­pean Par­lia­ment access priv­i­leges in response to Bourla’s refusal to tes­ti­fy. It’s hap­pened in the past: Law­mak­ers vot­ed to ban Mon­san­to lob­by­ists in 2017 after the com­pa­ny refused to turn up to a hear­ing. But it’s not auto­mat­ic — the deci­sion would have to be approved through the Par­lia­men­t’s inter­nal process­es. And indi­vid­ual MEPs can con­tin­ue to sign in Pfiz­er lob­by­ists as pri­vate guests.

    ...

    ———-

    “MEPs want to grill von der Leyen over Pfiz­er vac­cine con­tract” By Car­lo Mar­tus­cel­li; Politico.eu; 01/11/2023

    “Law­mak­ers want to ask von der Leyen about her role nego­ti­at­ing a mas­sive, multi­bil­lion euro coro­n­avirus vac­cine con­tract signed at the height of the pan­dem­ic. It was in the run-up to this con­tract that she is report­ed to have exchanged text mes­sages with Pfiz­er’s Chief Exec­u­tive Albert Bourla.

    What hap­pened to the text mes­sages exchanged between EU Com­mis­sion Pres­i­dent Ursu­la von dery Leyen and Pfiz­er CEO Albert Bourla exchanged dur­ing the lead up to the mas­sive multi­bil­lion euro vac­cine con­tract? *Poof* All gone. But it’s not just that law­mak­ers can’t get their hands on those texts. They can’t get a straight answer from either von der Leyen or Bourla, who both resist­ed par­lia­men­tary invi­ta­tion to explain their actions. It’s not just a cov­er up. It’s a cov­er up being done right out in the open:

    ...
    “The Euro­pean Union has spent a lot of pub­lic resources into the pro­duc­tion and pur­chase of vac­cines dur­ing the pan­dem­ic,” Van Brempt said in the state­ment. “[T]he Par­lia­ment has the right to obtain full trans­paren­cy on the modal­i­ties of these expen­di­tures and the pre­lim­i­nary nego­ti­a­tions lead­ing up to them.”

    So far, the Com­mis­sion Pres­i­dent has dodged ques­tions about what went down in those cru­cial months.

    Nei­ther the EU’s ombuds­man or the Court of Audi­tors have been able to shed a light on the murky deal­ings. The Euro­pean Pub­lic Pros­e­cu­tor’s Office, which is armed with legal pow­ers that the oth­er watch­dog agen­cies lack, has opened an inves­ti­ga­tion into the vac­cine con­tracts, with­out say­ing whether the Com­mis­sion Pres­i­dent is its tar­get.

    The COVID pan­el has been look­ing into the deal — the third and largest con­tract signed with Pfiz­er and its Ger­man part­ner BioN­Tech — and has so far heard from both the Court of Audi­tors and the ombuds­man. But Bourla refused the sum­mons, send­ing an under­ling in his stead.

    Fol­low­ing the Par­lia­men­t’s rules, the invite will be sent to Par­lia­ment Pres­i­dent Rober­ta Met­so­la, who will decide then whether to ask von der Leyen to attend the hear­ing. Met­so­la is a mem­ber of the cen­ter-right Euro­pean Peo­ple’s Par­ty group, the same one that placed the Com­mis­sion Pres­i­dent in her role.

    The invi­ta­tion, if it does arrive, does­n’t have any legal force. Like Bourla, von der Leyen can refuse to appear. But with calls for greater trans­paren­cy grow­ing loud­er as the Qatar­gate cor­rup­tion scan­dal engulfs Brus­sels, she may feel like she can’t say no.
    ...

    That as the sta­tus of the inquiry back in Jan­u­ary. Flash for­ward to a cou­ple of weeks ago and we got the fol­low­ing updates: First, the New York Times was suing the EU Com­mis­sion for the release of the texts. Then, a cou­ple days lat­er, we are informed that the Con­fer­ence of Presidents—the EU Parliament’s polit­i­cal lead­ers— decid­ed to sim­ply hold ‘an exchange of views’ with Ursu­la von der Leyen in a pri­vate ses­sion:

    The Euro­pean Con­ser­v­a­tive

    Noth­ing To Hide? Von der Leyen To Be Ques­tioned Behind Closed Doors

    Calls for trans­paren­cy in the EU insti­tu­tions are only grow­ing loud­er in the wake of Qatar­gate. As such, this new deci­sion for pri­vate ques­tion­ing will dam­age the cred­i­bil­i­ty of the EU Par­lia­ment.

    Tad­hg Pid­geon
    — Feb­ru­ary 16, 2023

    Ursu­la von der Leyen will like­ly be ques­tioned by EU par­lia­men­tary offi­cials behind closed doors for her role in the EU’s vac­cine pro­cure­ment deal, anony­mous sources close to the EP admin­is­tra­tion have just revealed to The Euro­pean Con­ser­v­a­tive. Many MEPs had been call­ing for a trans­par­ent inves­ti­ga­tion of the Com­mis­sion president’s actions, but it appears they will not get their way.

    The EU Parliament’s COVID-19 Com­mit­tee vot­ed last month to invite von der Leyen to pub­licly answer ques­tions from the pan­el. By pro­ce­dure, the invi­ta­tion was for­ward­ed for a deci­sion to the pres­i­dent of the par­lia­ment, Rober­ta Met­so­la.

    Instead, the Con­fer­ence of Presidents—the EU Parliament’s polit­i­cal leaders—have just now, at their meet­ing with Met­so­la, decid­ed to sim­ply hold ‘an exchange of views’ with Ursu­la von der Leyen in a pri­vate ses­sion.

    Sources also con­firmed that at the Con­fer­ence, only rep­re­sen­ta­tives of the ECR and ID Groups protest­ed against the deci­sion, on the grounds that the inquiry should be held open­ly and include more MEPs—which a ques­tion­ing in front of the COVID com­mit­tee would have done.

    This comes as the Euro­pean Com­mis­sion is being tak­en to court by the New York Times for fail­ing to release the text mes­sages between Pres­i­dent von der Leyen and Pfiz­er CEO Albert Bourla. Addi­tion­al­ly, French and Ital­ian media have point­ed out that her hus­band Heiko von der Leyen was a sci­en­tif­ic direc­tor at Orge­n­e­sis, a Pfiz­er sub­sidiary, which received some €320 mil­lion in funds from the Ital­ian gov­ern­ment, rais­ing sus­pi­cions that the agree­ment between the Com­mis­sion pres­i­dent and Pfiz­er may have been self-serv­ing.

    ...

    COVID-19 Com­mit­tee chair, Social­ist MEP Kath­leen Van Brempt, insist­ed a clear account­ing be made of EU expens­es:

    The Euro­pean Union has spent a lot of pub­lic resources on the pro­duc­tion and pur­chase of vac­cines dur­ing the pan­dem­ic, the Par­lia­ment has the right to obtain full trans­paren­cy on the modal­i­ties of these expen­di­tures and the pre­lim­i­nary nego­ti­a­tions lead­ing up to them.

    Anoth­er active mem­ber of the com­mit­tee, Cris­t­ian Tehre, a Roman­ian MEP with the ECR Group, called into ques­tion von der Leyen’s integri­ty:

    The man­date of Ursu­la von der Leyen as pres­i­dent of the Euro­pean Com­mis­sion is a com­plete fail­ure. Her refusal to dis­close the con­tracts, as well as her back door deals, to not come and answer ques­tions from MEPs in an open ses­sion proves that she is total­ly unfit for the job. She has to come into the Par­lia­ment and answer ques­tions in a pub­lic ses­sion in the COVID Com­mit­tee not because we say so, but because it is the right thing to do.

    In short, if there is noth­ing to hide, why is von der Leyen hid­ing?

    ————

    “Noth­ing To Hide? Von der Leyen To Be Ques­tioned Behind Closed Doors” by Tad­hg Pid­geon; The Euro­pean Con­ser­v­a­tive; 02/16/2023

    “Instead, the Con­fer­ence of Presidents—the EU Parliament’s polit­i­cal leaders—have just now, at their meet­ing with Met­so­la, decid­ed to sim­ply hold ‘an exchange of views’ with Ursu­la von der Leyen in a pri­vate ses­sion.”

    They tried to get Ursu­la von der Leyen to pub­licly answer these ques­tions. The EU Parliament’s COVID-19 Com­mit­tee vot­ed back in Jan­u­ary to make the invi­ta­tion for a pub­lic response. An invi­ta­tion that, as we saw above, von der Leyen had no legal oblig­a­tion to com­ply with. And it appears she used that pow­er to refuse the invite with this report from a cou­ple of weeks ago about the “Con­fer­ence of Pres­i­dents” decid­ing to instead hold a pri­vate ‘exchange of views’:

    ...
    The EU Parliament’s COVID-19 Com­mit­tee vot­ed last month to invite von der Leyen to pub­licly answer ques­tions from the pan­el. By pro­ce­dure, the invi­ta­tion was for­ward­ed for a deci­sion to the pres­i­dent of the par­lia­ment, Rober­ta Met­so­la.

    ...

    This comes as the Euro­pean Com­mis­sion is being tak­en to court by the New York Times for fail­ing to release the text mes­sages between Pres­i­dent von der Leyen and Pfiz­er CEO Albert Bourla. Addi­tion­al­ly, French and Ital­ian media have point­ed out that her hus­band Heiko von der Leyen was a sci­en­tif­ic direc­tor at Orge­n­e­sis, a Pfiz­er sub­sidiary, which received some €320 mil­lion in funds from the Ital­ian gov­ern­ment, rais­ing sus­pi­cions that the agree­ment between the Com­mis­sion pres­i­dent and Pfiz­er may have been self-serv­ing.
    ...

    .
    And note the dis­turb­ing appar­ent rel­a­tive lack of par­lia­men­tary con­cern over these cor­rup­tion issues: it was appar­ent­ly only rep­re­sen­ta­tives of the cen­ter-right ECR and far right ID Groups who protest­ed this capit­u­la­tion. It does­n’t bode well:

    ...
    Sources also con­firmed that at the Con­fer­ence, only rep­re­sen­ta­tives of the ECR and ID Groups protest­ed against the deci­sion, on the grounds that the inquiry should be held open­ly and include more MEPs—which a ques­tion­ing in front of the COVID com­mit­tee would have done.
    ...

    Will the EU’s con­ser­v­a­tives ulti­mate­ly hold Ursu­la von der Leyen’s feet to the fire over cor­po­rate cor­rup­tion? Hold­ing politi­cians account­able for being cor­rupt cor­po­ratists isn’t exact­ly a typ­i­cal right-wing theme. But it appears that the EU’s right-wingers are the only ones ani­mat­ed by the issue, which is all the more remark­able giv­en von der Leyen’s con­ser­v­a­tive cre­den­tials. Are we see­ing sort sort of intra-right-wing pow­er play at work? Time will tell, but it does­n’t appear we should expect any pub­lic rev­e­la­tions about the behind-the-scenes deal­ings that went into that multi­bil­lion euro COVID vac­cine con­tract. It’s not actu­al­ly clear what to expect at this point. Oth­er than more rushed exper­i­ment mRNA vac­cines. We can pre­sum­ably expect a lot more of those.

    Posted by Pterrafractyl | March 2, 2023, 5:41 pm

Post a comment